​What are you looking for?

Highlights from the CHMP Feb 2026 Meeting are out! New Medicines 💊  Ipsen 's tovorafenib (Ojemda; Type II RAF kinase inhibitor) is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies New Biosimilars 💊  Henlius  and  Organon 's pertuzumab (Poherdy; HER2/neu receptor antagonist), an interchangeable biosimilar biological product to pertuzumab (Perjeta) is intended for the treatment of breast cancer Indication Expansions 💊 Merck & Co/ MSD 's pembrolizumab (Keytruda; anti-PD-1 mAb) in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens 💊  Novartis ' asciminib (Scemblix; STAMP inhibitor) is indicated for the treatment of adult patients with Ph+ chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib 👉 Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at support@oncofocus.com , and we will take it from there. 🌐 Reference:  https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-february-2026

26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC ( Ref ) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-authorized test. This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program The approval is based on results from the Phase 1 Beamion LUNG-1 trial (NCT04886804) Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC ( Ref ) Positive topline results have been reported from a pre-specified interim analysis of a Phase 3 BL-B01D1-307 trial evaluating SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR × HER3 bispecific ADC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose disease progressed following prior taxane therapy. In the pre-specified interim analysis, iza-bren demonstrated statistically significant and clinically meaningful improvement in both PFS and OS vs chemotherapy of physician’s choice, meeting both dual primary endpoints These data will be presented at an upcoming medical meeting The BL-B01D1-307 study is sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), in Mainland China Outside of China, iza-bren is jointly developed by SystImmune and BMS under a collaboration and exclusive license agreement

24/02/2026 Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC ( Ref ) The US FDA granted traditional approval to Pfizer's encorafenib (BRAF inhibitor) + cetuximab + fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test. The approval has been granted based on results from the Phase 3 BREAKWATER trial (NCT04607421), a randomized, active-controlled, open-label, multicenter study in patients with treatment-naïve, BRAF V600E mutation–positive, metastatic CRC Encorafenib had received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024 Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG ( Ref ) The US FDA granted the fast track designation to Siren Biotechnology's SRN-101 (AAV-based immuno-gene therapy) for the treatment of recurrent high-grade glioma (HGG). Siren recently announced FDA clearance of its first IND filing for SRN-101, enabling first-in-human clinical evaluation in patients with recurrent high-grade glioma Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC ( Ref ) The US FDA granted the fast track designation to Aktis Oncology's AKY-1189 (alpha-emitting radiopharmaceutical targeting Nectin-4) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies. Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) of AKY-1189 in the United States for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer Aktis expects to present preliminary results from Part 1 of the trial in the first quarter of 2027 Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC ( Ref ) The US FDA granted the orphan drug designation to Onconic Therapeutics' nesuparib (dual inhibitor of PARP and TNKS) for the treatment of small cell lung cancer. " The FDA highly valued the potential of nesuparib's dual mechanism in suppressing two core survival axes of cancer cells. We expect the drug to offer a new alternative for patients with recurrent or treatment-resistant small cell lung cancer ," an Onconic Therapeutics official said.

23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer ( Ref ) The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA-mutated, HER2-ve, locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor. The designation has been granted based on data from the ongoing, first-in-human, Phase 1/2a study (NCT05898399) This designation will enable Artios to interact more frequently and earlier with the FDA to discuss ART6043’s development path RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC ( Ref ) The EC has approved an extension of Johnson & Johnson's RYBREVANT (amivantamab) marketing authorisation to include additional subcutaneous (SC) dosing regimens. With this decision, SC amivantamab is now authorised for use across all previously approved intravenous (IV) amivantamab indications, including: Every-four-week (Q4W) SC amivantamab dosing regimen: In combination with lazertinib for first-line treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations As monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy Every-three-week (Q3W) SC amivantamab dosing regimen in combination with carboplatin and pemetrexed for adult patients with advanced NSCLC: With EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI) With activating EGFR exon 20 insertion mutations, as first-line treatment The approval is supported by results from the Phase 2 PALOMA-2 and Phase 1 PALOMA studies

Bristol Myers Squibb 's Q4 2025 earnings call spotlighted key milestones for the Opdualag franchise in melanoma 📊 Blockbuster Status and US Dominance Four years post-launch, Opdualag reached blockbuster status with 2025 global revenues of $1,185M, driven by $1,045M in the US. It has captured over 30% US market share, cementing its role as a standard-of-care option for metastatic melanoma. The ex-US market remains largely untapped with sales generating only $140M, constrained by restricted labeling and reimbursement barriers. 🎯 European Label Extension Filing BMS has submitted a filing to the European Medicines Agency for label expansion to encompass advanced melanoma patients with PD-L1 expression ≥1% (presently approved solely for PD-L1 <1%). This application rests on the 4-year update from the Phase 2/3 RELATIVITY-047 trial, assessing Opdualag in first-line advanced melanoma. Compared to preliminary findings, long-term outcomes demonstrated enhanced overall survival (OS), evidenced by a reduced hazard ratio and confidence interval upper bound below 1. The safety profile exhibited stability, with merely numerical elevations in adverse event rates over time. 🛑 Pipeline Setbacks in Melanoma The Phase 3 RELATIVITY-127 trial for subcutaneous Opdualag in first-line melanoma—originally slated for H2 2025 readout—was removed from BMS's pipeline, marking the second Phase 3 failure in melanoma after RELATIVITY-098 in the adjuvant setting. Without disclosed reasons, likely endpoint misses or limited commercial upside (post-adjuvant failure) drove this decision. 📝 Implications Amid these Phase 3 setbacks, the EU filing represents BMS's critical push to broaden Opdualag's global melanoma share. If approved (decision expected in Q2 2026), it would unlock a major EU market currently inaccessible due to PD-L1 restrictions, potentially mirroring the growth trajectory in the US.  🌐 Reference: https://bristolmyers2016ir.q4web.com/iframes/events-and-presentations/event-details/2026/Bristol-Myers-Squibb-Q4-2025-Results-Conference-Call/default.aspx

Welcome to the January edition of our CGT Watch newsletter! Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear Readers, We’re excited to bring you Jan edition of CGT watch highlighting updates on novel targets, innovative approaches, first-of-its-kind combinations, and key developments. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. 🎯 Regulatory Updates ⭐   The FDA cleared IND for Kelonia’s KLN-1010, advancing  in vivo  BCMA CAR-T therapy in R/R MM. ( Ref ) Kelonia Therapeutics   secured FDA IND clearance for KLN-1010 ( in-vivo;  anti-BCMA CAR-T) enabling US expansion of their Ph1 trial. To note, early MRD-negative responses have been observed in R/R Multiple Myeloma pts treated at sites in Australia. 👉   Why It Matters:  KLN-1010 could reshape CAR-T therapy by generating anti-BCMA CAR-T cells   in-vivo   with a single infusion removing complex manufacturing and preconditioning chemotherapy.   ⭐   FDA greenlights A2B543, expanding A2 Bio’s Tmod™ platform into advanced solid tumors ( Ref ) A2 Biotherapeutics, Inc.   secured FDA IND clearance for A2B543, (a logic-gated, anti-MSLN CAR-T) for the treatment of solid tumours and expanding the EVEREST-2 precision medicine trial. 👉   Why It Matters:  A2B543 brings a novel IL-12 boosted Tmod™ cell therapy into clinical trials for solid tumors, marking a major step in expanding precision, logic-gated immunotherapies to patients with few treatment options.   ⭐   FDA cleared Arovella’s game-changing off-the-shelf iNKT CAR Therapy for clinical studies ( Ref ) FDA accepted IND application for   Arovella Therapeutics ASX: ALA 's ALA-101, (an allogeneic, anti-CD19 CAR-iNKT), enabling Ph1 trials in Australia and US for R/R NHL and leukemia. 👉   Why It Matters:  ALA-101 signals a shift beyond conventional CAR-T toward invariant NKT-powered immune engineering.   ⚡️ Special Designations   ⭐   Eureka’s next-gen ARTEMIS® CAR-T ECT204 earned FDA RMAT status for Liver Cancer ( Ref ) The FDA granted RMAT designation to   Eureka Therapeutics, Inc ' ECT204 ARTEMIS® (an autologous anti-GPC3 CAR-T) for advanced HCC, based on promising Ph 1/2 ARYA-3/NCT04864054 data. 👉   Why It Matters : If successful, ARTEMIS could unlock a modular CAR-T platform adaptable across multiple solid tumor indications.   ⭐   FDA breakthrough designation accelerates Wugen’s allogeneic CD7 CAR-T Sofi-cel ( Ref ) Wugen   received FDA Breakthrough Therapy Designation for Sofi-cel (off-the-shelf; anti-CD7 CAR-T) which is being evaluated in patients with R/R T-ALL and T-LBL in the Ph2 T-RRex/NCT06514794 trial. 👉   Why It Matters : Sofi-cel could become the first off‑the‑shelf CAR‑T option for R/R T‑ALL/T‑LBL, addressing a critical unmet need.   ⭐   FDA granted Orphan Drug Designation to Imviva’s off-the-shelf CD7 CAR-T CTD402 for R/R T-ALL/LBL ( Ref ) Imviva Biotech 's CTD402 (an off-the-shelf, anti-CD7 CAR-T) received ODD from the US FDA for R/R T-ALL/LBL, with early CR rate of 64.1% in the ongoing Ph1/2 TENACITY-01/NCT07070219 trial. 👉   Why It Matters : CTD402’s early CR and MRD negative rates highlight the clinical potential of off-the-shelf CAR-T in aggressive T-cell malignancies.   🔬 Clinical Outcomes   ⭐   Immunofoco has advanced its solid tumor CAR-T program as IMC002 demonstrated strong clinical activity in GC/GEJ ( Ref ) Immunofoco presented results from the IMC002-RT01/NCT05946226 trial in which IMC002 (VHH-based anti-CLDN18.2 CAR-T) showed 66.7% ORR and 7.0m PFS in heavily pretreated GC/GEJ patients. 👉   Why It Matters : Durable complete responses beyond 60 weeks highlight CAR-T’s potential for long-term control in advanced gastric cancer, while VHH-based CAR design signals safer, more precise targeting in solid tumors.   🤝 Deals & Collaborations   ⭐   India’s indigenous CAR-T therapy Talicabtagene Autoleucel has entered into African markets via Cipla ( Ref ) Cipla licensed   ImmunoACT 's Talicabtagene autoleucel (an autologous anti-CD19 CAR-T) for exclusive commercialization in South Africa, Algeria and Morocco to address unmet needs in R/R B-NHL and B-ALL. 👉   Why It Matters:  This collaboration could establish Africa’s first large‑scale CAR‑T footprint, reshaping hematology treatment standards across the continent.   ⭐ AdAlta linked major CAR-T deal for global development outside China ( Ref ) AdAlta Ltd   secured exclusive global rights (ex-China) to co-develop SHcell's promising BZDS1901 (PD1-armored Anti-MSLN CAR-T) therapy, validating its East-to-West strategy with AdCella funding Ph1 trials in Australia. 👉   Why It Matters:   The deal gives AdAlta control of a high-value CAR-T in Western markets, anchors early development and manufacturing in Australia, and positions it as a gateway for Asian cell-therapy innovation into global oncology pipelines   ⭐ Nona Biosciences and Link Cell Therapies partnered to discover next-gen CAR-Ts ( Ref ) Nona Biosciences   partnered with Link Cell Therapies to discover novel fully human HCAb-based CAR-T candidates using HCAb Harbour Mice® and NonaCarFx™ platforms for solid and hematologic malignancies. 👉   Why It Matters:   By pairing Nona’s antibody platforms with Link’s logic-gated CARs, the partnership could redefine precision therapy for solid tumors.   ⭐ CARsgen and Dispatch Bio team up to unlock CAR-T potential in Epithelial Solid Tumors ( Ref ) CARsgen Therapeutics   & Dispatch Bio have planned to launch Phase 1 China trial combining Dispatch's Flare platform (DV-10 tumor virus) + CARsgen's Zevor-cel (anti-BCMA CAR-T) for epithelial solid tumors in 2026. 👉   Why It Matters:  If DV‑10 successfully primes epithelial tumors, CAR T could finally break through the barrier of antigen scarcity in solid cancers.   🚀 Product Launch   ⭐   Immuneel launched Qartemi® India’s first globally benchmarked CAR-T therapy, redefining treatment for  NHL ( Ref ) Immuneel Therapeutics Pvt. Ltd.   launched Qartemi®, India's first globally benchmarked CAR T-cell therapy for R/R B-NHL which demonstrated 83.3% ORR in the IMAGINE trial. 👉   Why It Matters:   Qartemi® is India’s first globally benchmarked CAR-T therapy for R/R NHL, delivering world-class personalized treatment at an accessible cost through local manufacturing redefining precision oncology in India. A Request We’d love your feedback, what did you find most interesting? If you have any questions or insights, feel free to reply or reach out. We look forward to exploring more breakthroughs with you in our next newsletter. Until next time, The CGT Watch Team

20/02/2026 The combination of venetoclax and acalabrutinib has been approved by the US FDA for CLL The combination of venetoclax and acalabrutinib has been approved by the US FDA for CLL ( Ref ) The US FDA has approved a sNDA for Abbvie & Genentech's venetoclax (BCL-2 inhibitor) + AstraZeneca's acalabrutinib (BTK inhibitor) for the treatment of previously untreated adult patients with CLL The approval is supported by data from the Phase 3 AMPLIFY trial Dr. Brian Koffman, co-founder and chief medical officer emeritus, CLL Society: " With the FDA approval of the combination of venetoclax and acalabrutinib for use as a front-line therapy in CLL, patients in the USA now have an all oral, time-limited option that can be important for many in choosing their treatment. CLL Society is pleased to see the number of choices available for patients growing ."

19/02/2026 Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer  Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer ( Ref ) The EMA has validated the type II variation marketing authorization application for AstraZeneca & Daiichi Sankyo's ENHERTU® (trastuzumab deruxtecan; HER2 ADC) monotherapy for adult patients with HER2 +ve breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. The validation confirms the completion of the application and commences the scientific review process by the EMA’s CHMP The filing is based on data from the Phase 3 DESTINY-Breast05 trial presented at the 2025 ESMO Congress and subsequently published in The New England Journal of Medicine Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC ( Ref ) The US FDA granted the Fast Track designation to Pilatus Biosciences' PLT012 (anti-CD36) for the treatment of hepatocellular carcinoma (HCC). Pilatus is also developing PLT012 in additional solid tumor indications. Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences: “ Receiving FDA Fast Track designation for PLT012 is an important milestone that reinforces the potential of our checkpoint therapy approach to transform the treatment of HCC. PLT012 was designed to address the metabolic adaptations that drive immune evasion in cancer. With IND clearance already secured and our Phase 1 trial open for patient enrollment, this designation will help accelerate clinical development and advance towards delivering a novel therapeutic option for patients, both in HCC and other solid tumors where patients do not benefit from existing immunotherapies .” Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer ( Ref ) The US FDA has accepted Genentech's NDA for giredestrant (estrogen receptor degrader and full antagonist) in combination with everolimus for the treatment of adult patients with ER+ve, HER2-ve, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by December 18, 2026 The filing acceptance is based on the Phase III evERA Breast Cancer study results

February 2nd Week, 2026 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD 's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1), and who have received one or two prior systemic treatment regimens. (Ref 1) ❓ What are the clinical outcomes that support this approval? 🎯 The US FDA completed its filing review and accepted filing of  Biofrontera Inc. 's sNDA for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED® red-light lamp series for the treatment of Superficial Basal Cell Carcinoma. (Ref 2) ❓ What is the current SOC for sBCC? Special Designations ⭐ The US FDA granted the Fast Track Designation to Abbisko Therapeutics' ( 和誉医药 ) irpagratinib (FGFR4 inhibitor) for the treatment of patients with hepatocellular carcinoma with FGF19 overexpression who have been previously treated with ICIs and multi-TKl therapies. (Ref 3) ❓ Which are the key promising assets in the HCC pipeline landscape? ⭐ The US FDA granted the Orphan Drug Designation to  HanchorBio Inc. 漢康生技股份有限公司 's HCB101 (CD47–SIRPα pathway inhibitor) for the treatment of gastric cancer. (Ref 4) ❓ What are the key unmet medical needs of this indication?  ⭐ The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) Designation to  Krystal Biotech, Inc. 's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced or metastatic NSCLC. (Ref 5) ❓ What are the launch timeline estimates for this regimen? Setbacks 🛑  AstraZeneca  announced the discontinuation of the  Daiichi Sankyo US  -partnered Phase 3 TROPION-Lung12/NCT06564844 trial of datopotamab deruxtecan (TROP2 ADC) + rilvegostomig (PD-1 x TIGIT BsAb) or rilvegostomig mono vs standard of care in stage I adenocarcinoma NSCLC who are ctDNA-positive or have high-risk pathological features (Ref 6) ❓ How are key competitors positioned in the development landscape for adjuvant NSCLC? To know answers to these questions and for additional insights, write to us at  support@oncofocus.com .  🌐 References:  1) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or?utm_medium=email&utm_source=govdelivery 2) https://www.biospace.com/press-releases/biofrontera-announces-fda-filing-acceptance-of-supplemental-new-drug-application-for-ameluz-pdt-in-superficial-basal-cell-carcinoma 3) https://www.abbisko.com/newsDetail/236.html 4) https://www.biospace.com/press-releases/hanchorbio-receives-fda-orphan-drug-designation-for-hcb101-in-gastric-cancer 5) https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-rmat-designation-granted-fda-kb707 6) https://www.astrazeneca.com/content/dam/az/PDF/2025/Q4-FY/Full-year-Q4-2025-clinical-trial-appendix.pdf#page=16

18/02/2026 ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS ( Ref ) The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) + Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive NMIBC CIS, with or without papillary tumors. ANKTIVA + BCG is the first authorized treatment in Europe for BCG-unresponsive NMIBC CIS The conditional marketing authorization follows the positive opinion adopted by the CHMP, and is based on results from the Ph2/3 QUILT-3.032 study (NCT03022825) Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN ( Ref ) The US FDA granted the Breakthrough Therapy Designation to Johnson & Johnson's subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with HPV-unrelated R/M SCCHN after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The BTD is supported by data from the open‑label Phase 1b/2 OrigAMI‑4 study Based on these findings, subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study (NCT07276399), which is assessing the subcutaneous amivantamab + pembrolizumab + carboplatin vs pembrolizumab + platinum-based chemotherapy + 5FU as a first-line treatment in patients with HPV-unrelated R/M SCCHN, regardless of PD-L1 expression

17/02/2026 Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL ( Ref ) The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deciphera Pharmaceuticals' tirabrutinib (Bruton tyrosine kinase inhibitor) for the treatment of relapsed or refractory primary central nervous system lymphoma (R/R PCNSL). The FDA has set a PDUFA action date of December 18, 2026 The NDA is supported by the positive results from the Phase 2 PROSPECT study J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC ( Ref ) The US FDA approved a new, simplified monthly dosing schedule for Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of EGFR-mutated advanced NSCLC, monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule Danny Nguyen, M.D., Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, and principal investigator for the PALOMA-3 and MARIPOSA studies: “ A monthly dosing schedule offers patients convenience without sacrificing efficacy. With a flexible schedule that reduces time in the clinic, patients may be able to stay on therapy longer and free up time to focus on the moments that matter most .” BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM ( Ref ) The US FDA has accepted Bristol Myers Squibb's NDA for iberdomide (CELMoD agent) + standard treatment (daratumumab + dexamethasone - IberDd) in patients with relapsed or refractory multiple myeloma (R/R MM). The FDA has granted a PDUFA date of August 17, 2026 The filing was based on results from a planned analysis of MRD negativity rates in the Phase 3 EXCALIBER-RRMM study

16/02/2026 Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC Phase 3 LIBRETTO-432 trial of adjuvant selpercatinib met the EFS endpoint in RET fusion positive NSCLC ( Ref ) Eli Lilly and Company announced positive topline results from the Phase 3 LIBRETTO-432 clinical trial of selpercatinib (Retevmo; RET kinase inhibitor) as an adjuvant therapy versus placebo in patients with early-stage (II-IIIA) RET fusion-positive NSCLC. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed EFS OS results trended in favor of selpercatinib, but were immature at the time of this analysis with few events observed The overall safety profile of selpercatinib in LIBRETTO-432 was generally consistent with previously reported trials in the selpercatinib development program