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10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC ( Ref ) The US FDA granted the fast track designation to Abbisko Therapeutics' irpagratinib (FGFR4 inhibitor) for the treatment of patients with hepatocellular carcinoma (HCC) with FGF19 overexpression who have been previously treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKls) therapies. The designation is primarily based on positive results from a Phase 1 clinical study presented at the 2024 ESMO Annual Congress In May 2025, irpagratinib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer ( Ref ) 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) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. The FDA also approved the PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc) as a companion diagnostic device to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) for treatment with pembrolizumab. The approval was granted based on positive results from the Phase 3 KEYNOTE-B96 (NCT05116189) trial

February 1st Week, 2026 Regulatory Events 🎯 The US FDA approved an update to  Gilead Sciences ' axicabtagene ciloleucel (anti-CD19 CAR-T) prescribing information removing the previous “Limitations of Use” in patients with relapsed/refractory primary central nervous system lymphoma (Ref 1) ❓ How would this decision alter Yescarta’s positioning in the market landscape? 🎯  AstraZeneca  and  Daiichi Sankyo US ’ sBLA for datopotamab deruxtecan (TROP2 ADC) was accepted and granted a Priority Review in the US for the Tx of unresectable/metastatic triple-negative breast cancer patients who are not candidates for PD-(L)1 inhibitors (Ref 2) ❓ What are the clinical outcomes supporting this Priority review? 🎯  OS Therapies  has initiated a BLA submission to the US FDA for OST-HER2 (HER2 targeted vaccine) in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Ref 3) ❓ What is the current SOC for osteosarcoma? 🎯 The US FDA has accepted  Exelixis ' NDA for zanzalintinib (multi-TKI) +  Roche 's atezolizumab (anti-PD-L1) for the Tx of adults with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemo, and, if RAS WT, an anti-EGFR (Ref 4) ❓ How does zanzalintinib compare to other key late-stage assets being developed for mCRC? Special Designations ⭐ The US FDA granted the orphan drug designation to  Partner Therapeutics ' zenocutuzumab (HER2xHER3 BsAb) for the Tx of advanced unresectable/metastatic cholangiocarcinoma (Ref 5)  ❓ Which other HER2 targeting therapies are being developed for this indication?  ⭐ The US FDA granted the fast-track designation to  Oncolytics Biotech Inc. 's pelareorep (oncolytic virus) + bevacizumab + FOLFIRI for KRAS-mutant, MSS mCRC in the second-line setting (Ref 6) ❓ Which are the key promising assets in this indication? ⭐ The US FDA granted the breakthrough therapy designation to  Relay Therapeutics ' zovegalisib (PI3Kα inhibitor) + fulvestrant for the Tx of PIK3CA mutant, HR +, HER2-, LA/M breast cancer following recurrence or progression on or after Tx with a CDK4/6 inhibitor (Ref 7) ❓ What are the launch timeline estimates for this regimen? ⭐ The US FDA granted the orphan drug designation to  TuHURA Biosciences, Inc. ' IFx-2.0 (innate immune agonist) for the Tx of stage IIB-IV cutaneous melanoma (Ref 8)  ❓ What are the key unmet medical needs of this indication?  To know answers to these questions and for additional insights, write to us at  support@oncofocus.com . 🌐 References:  1) https://www.gilead.com/news/news-details/2026/fda-approves-label-update-for-kites-yescarta-for-relapsedrefractory-primary-central-nervous-system-lymphoma 2) https://www.astrazeneca.com/media-centre/press-releases/2026/datroway-granted-priority-review-in-the-us-as-1st-line-treatment-for-patients.html 3) https://ir.ostherapies.com/news-events/press-releases/detail/98/os-therapies-initiates-us-fda-bla-filing-for-ost-her2-in 4) https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-us-fda-accepted-new-drug-application 5) https://www.partnertx.com/zenocutuzumab%e2%80%91zbco-receives-fda-orphan-drug-designation-for-treatment-of-cholangiocarcinoma/ 6) https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-receives-fda-fast-track-designation-for-pelareorep-in-2l-kras-mutant-mss-metastatic-colorectal-cancer/ 7) https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-zovegalisib-granted-breakthrough 8) https://ir.tuhurabio.com/news-events/press-releases/detail/35/tuhura-biosciences-received-fda-orphan-drug-designation-for-ifx-2-0-for-the-treatment-of-stage-iib-to-stage-iv-cutaneous-melanoma

09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec'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. Suma Krishnan, President of Research and Development, Krystal Biotech: “ The FDA’s decision to grant RMAT designation to KB707 reflects both the urgent unmet need for new NSCLC therapies as well as the promising early clinical evidence of efficacy we have observed with inhaled KB707 in patients with advanced NSCLC. “This is the second RMAT designation granted to a Krystal program and, as such, we know first-hand the benefits that this designation can provide to accelerate development and shorten the path to a potential approval. We are excited to work closely with the FDA to maximize the potential impact of our KB707 program for patients with NSCLC .”

Highlights from the CHMP Jan 2026 Meeting are out! Indication Expansions 💊  Johnson & Johnson Innovative Medicine 's niraparib & abiraterone acetate co-formulation (Akeega; PARP x CYP17 inhibitor) is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic) 💊  Incyte  and  Takeda 's ponatinib (Iclusig; multi-target kinase inhibitor) is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) 💊  AstraZeneca 's durvalumab (Imfinzi; anti-PD-L1) in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant durvalumab monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma 💊  Bristol Myers Squibb 's nivolumab (Opdivo; anti-PD-1) in combination with  Pfizer  &  Takeda 's brentuximab vedotin (CD30 targeting ADC) is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy 💊  MacroGenics, Inc. ,  Incyte  &  Zai Lab 's retifanlimab (Zynyz; anti-PD-1) is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC) 👉 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-26-29-january-2026

05/02/2026 Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma ( Ref ) The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma.  Zenocutuzumab is being developed in a subset of patients with cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion Juan W. Valle, MD, CMO, Cholangiocarcinoma Foundation: “ Patients with cholangiocarcinoma face a particularly aggressive cancer with poor prognosis and limited treatment options. Receiving Orphan Drug Designation for zenocutuzumab in patients with CCA harboring the NRG1 gene fusion is a significant regulatory milestone for Partner Therapeutics and highlights the urgent need for new and effective treatment options for patients with this disease .”

06/02/2026 The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma ( Ref ) The US FDA approved an update to Gilead's Yescarta® (axicabtagene ciloleucel; anti-CD19 CAR T-cell therapy) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The FDA decision is based on positive results from a Phase 1 investigator-sponsored study conducted by Dana-Farber Cancer Institute, which included patients with R/R PCNSL. Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma, Dana-Farber Cancer Institute and Associate Professor of Neurology, Harvard Medical School: “ We are pleased that our study, which highlighted the safety of axi-cel in central nervous system lymphoma, supported the FDA’s decision. This update to the axi-cel prescribing information provides clinicians with important evidence for patients who have historically had very limited treatment options .”

04/02/2026 Oncolytics Biotech's pelareorep-based regimen received the FDA fast track designation for MSS CRC Oncolytics Biotech's pelareorep-based regimen received the FDA fast track designation for MSS CRC ( Ref ) The US FDA granted the fast track designation to Oncolytics Biotech's pelareorep (oncolytic virus) in combination with bevacizumab (Avastin®) and FOLFIRI for the treatment of patients with KRAS-mutant, MSS metastatic colorectal cancer in the second-line setting. The designation is supported by clinical data demonstrating a 33% ORR for pelareorep-based therapy compared to approximately 10% ORR with SOC in this patient population Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer ( Ref ) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults with PIK3CA mutant, HR positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor. BTD for zovegalisib was supported by clinical data generated to date from the Phase 1/2 ReDiscover trial Don Bergstrom, M.D., Ph.D., President of R&D, Relay Therapeutics: “Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options. This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients.” The US FDA granted priority review status to Datroway for the treatment of TNBC ( Ref ) AstraZeneca and Daiichi Sankyo’s sBLA for datopotamab deruxtecan (Datroway; TROP2 ADC) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The PDUFA date is anticipated during the second quarter of 2026 The sBLA is being reviewed under Project Orbis The sBLA is based on results from the Phase III  TROPION-Breast02 trial

02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma ( Ref ) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The non-clinical and the CMC modules of the BLA have been submitted to the FDA OS has requested for a Rolling Review The company expects to submit the clinical BLA module by the end of Mar 2026, keeping it on schedule to be eligible to receive approval by Sep 30, 2026 Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA ( Ref ) The US FDA accepted Exelixis' NDA for zanzalintinib (multi-TKI) + Roche's atezolizumab (anti-PD-L1) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-EGFR therapy The FDA assigned a standard review with a PDUFA target action date of Dec 03, 2026 The NDA is based on the results of the Phase 3 STELLAR-303 pivotal trial TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma ( Ref ) The US FDA granted the orphan drug designation to TuHURA Biosciences' IFx-2.0 (innate immune agonist) for the treatment of stage IIB to stage IV cutaneous melanoma. The ODD was based on data from the Company's previously completed Phase 1 study of IFx-2.0 in patients refractory to checkpoint inhibitor therapy (anti-PD1) Dr. James Bianco, President and Chief Executive Officer, TuHURA Biosciences: " Our current focus with IFx-2.0 is targeting completion of enrollment in our Phase 3 study of IFx-2.0 in combination with Keytruda® for the first-line treatment of advanced or metastatic Merkel Cell Carcinoma. We believe receiving ODD in advanced cutaneous melanoma demonstrates not only the significant need for new treatments in skin cancer but also highlights IFx-2.0 as a potential new therapeutic approach in this patient population ."

29/01/2026 Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia ( Ref ) The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX-2101 (oral arsenic trioxide capsule) for the treatment of patients with acute promyelocytic leukemia (APL). QTX-2101 is currently being evaluated in a global, multicenter, randomized, controlled Phase III clinical trial comparing the investigational oral capsule to standard-of-care therapy in patients with newly diagnosed APL The trial builds on pharmacokinetic and safety data from prior Phase I studies conducted in the United States Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC ( Ref ) The US FDA accepted Summit's Biologics License Application (BLA) seeking approval for Summit & Akeso's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy. The FDA provided a PDUFA goal action date of November 14, 2026 The BLA was submitted based on the overall results of the Phase III HARMONi trial The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC ( Ref ) The Phase III IMpower030 trial of neoadjuvant treatment with Roche's atezolizumab (anti-PD-L1) + platinum-based  chemotherapy followed by adjuvant treatment with atezolizumab alone in resectable stage II, IIIA, or select IIIB NSCLC failed to meet the primary endpoint. The perioperative regimen failed to meet the primary endpoint of Event Free Survival (EFS) vs neoadjuvant treatment with placebo + platinum-based chemotherapy

28/01/2026 Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma ( Ref ) Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib (FGFR2 inhibitor) as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement. Dong-Gun Kim, the company’s chief executive officer: “ This NDA reaffirms Elevar’s mission of bringing life-changing medicines to cancer patients worldwide, including for rare indications and for advanced stages where treatment options are limited. We are excited to work with the FDA as it reviews the submission while simultaneously preparing for a potential commercial launch. We could not be more appreciative of the patients who participated in lirafugratinib-focused clinical trials and everyone who brought us to this crucial point in its development .” The NDA is suppo rted by positive clinical data from the phase 1/2 ReFocus trial (NCT04526106)

27/01/2026 Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma ( Ref ) The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on the pivotal Phase 3 CEPHEUS/NCT03652064 trial Saad Z. Usmani, M.D., Chief, Myeloma Service, Memorial Sloan Kettering Cancer Center and CEPHEUS principal investigator: “ D-VRd increased the depth and durability of responses, significantly reduced the risk of disease progression or death, and nearly doubled the rate of sustained minimal residual disease (MRD)-negativity compared to VRd in patients ineligible for ASCT, solidifying this regimen as a potential standard of care for newly diagnosed patients with multiple myeloma. MRD-negativity is a potential predictor of prolonged progression-free and overall survival and D-VRd is now the only quadruplet regimen approved by the FDA based on a study with MRD-negativity as a primary endpoint .” Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL ( Ref ) The US FDA granted the orphan drug designation to Imviva Biotech's CTD402 (anti-CD7 CAR-T cell therapy) for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). CTD402 is currently being evaluated in the global Phase 1b/2 TENACITY-01/NCT07070219 trial Jan Davidson-Moncada, CMO, Imviva Biotech: " Receiving orphan drug designation for CTD402 is an important milestone for patients with relapsed or refractory T‑ALL/LBL, who urgently need more effective and accessible treatment options. This recognition provides regulatory support and extended market exclusivity to advance our development pathway, supporting our belief that a truly off‑the‑shelf CAR‑T therapy, available at the point of care, has the potential to change the treatment paradigm for these rapidly progressing diseases .” Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma ( Ref ) The US FDA granted the fast track designation to Nanjing Leads Biolabs' LBL-034 (GPRC5D x CD3 BsAb) for the treatment of relapsed/refractory multiple myeloma. LBL-034 has demonstrated promising efficacy signals in both preclinical and clinical studies and is currently undergoing Phase 1/2 trials to evaluate its potential for treating malignant plasma cell neoplasms