15/10/2026 US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors Revolution Medicines' RASONQUE receives positive CHMP opinion for Metastatic Pancreatic Cancer US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors (Ref) Marengo Therapeutics announced that the US FDA has granted a second Fast Track Designation (FTD) to Invikafusp alfa (STAR0602; bispecific dual T-cel

01/10/2026 Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC Trethera receives FDA Fast Track Designation for TRE-515 combination strategy in KRAS G12C-Mutant NSCLC Replimune announces US launch of TUDRIQEV™ for advanced Melanoma Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC (Ref) Cullinan Therapeutics announced the initiation of a US FDA New Drug Application (NDA) submission under the

30/09/2026 Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD Celcuity Announces US Commercial Launch of REVTORPYK (gedatolisib) Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD (Ref) Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, has resubmitted the Biologics License Application (BLA) for tabelecleucel (tab-cel; allogeneic, off-the-shelf Epstein-Barr virus (EBV)-specific cyto

28/09/2026 Evorpacept demonstrates efficacy benefit in HER2-retained/high-CD47 gastric cancer subsets, in Phase 2 ASPEN-06 study; ALX will not pursue a US registrational Phase 3 study, evaluates partnership opportunities Innovent expands Phase 3 MarsLight-11 trial of IBI363/TAK-928 in NSCLC AstraZeneca invests $2B in Summit Therapeutics to advance ivonescimab-ADC combination strategy across multiple cancers Teva Receives US FDA Approval for DEGEVMA, a biosimilar to Xgeva (den

25/09/2026 In Phase 3 EXCALIBER-RRMM trial, ZENBEXUS™-based therapy significantly improved response depth and MRD-negative CR versus DVd in RRMM In Phase 2 CARTITUDE-2 study, single CARVYKTI infusion delivered 5-year treatment-free remission in 50% of early-line RRMM patients US FDA granted priority review for imfinzi + enfortumab vedotin in cisplatin-ineligible MIBC MSD and Daiichi Sankyo have voluntarily withdrawn the US BLA for I-DXd in previously treated ES-SCLC In Phase

23/09/2026 US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma SOTIO Advances SOT106 with Additional FDA Designations in Sarcoma In Phase 3 MajesTEC-3 study, TECVAYLI + DARZALEX FASPRO demonstrates durable survival outcomes and substantial progression risk reduction in RRMM US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma (Ref) Elevar Therapeutics announced US FDA approval of LYRFIGTU™ (lirafugratinib), an irreversible

Highlights from the CHMP September 2026 Meeting are out! 📢 At the Sep'26 CHMP meeting, nine positive opinions related to oncology were reported. Here are the main highlights: 1) Cisplatin is no longer the gatekeeper in bladder cancer. 👉 The CHMP dropped the cisplatin-ineligibility restriction for Keytruda + Padcev in resectable muscle-invasive bladder cancer 2) The label race has moved upstream. 👉 All five oncology extensions took a therapy into an earlier setting or a wid

27/08/2026 US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer FDA clears path for Phase III melanoma trial of ruxotemitide + pembrolizumab NMPA conditional approval granted for Asandeutertinib in NSCLC with CNS metastases US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer (Ref) CytomX Therapeutics announced that the US FDA has granted Fast Track designation to Varsetatug masetecan (Varseta-M; EpCAM targeting ADC) for patient

24/08/2026 EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status US FDA accepts Jemperli for priority review in dMMR/MSI-H rectal cancer US FDA Fast Track designation granted for ERAS-0015 in metastatic pancreatic cancer; Phase 3 trial planned EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status (Ref) European Commission’s expanded approval of Gilead’s Trodelvy (sacituzumab govitecan-hziy; Trop-2–directe

17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

13/08/2026 US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma Celltrion announced that CT-P73, tissue factor–targeting ADC for recurrent/metastatic cervical cancer, received FDA fast track designation US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma (Ref) OS Therapies announced that the US FDA has granted a Type C Statistical Methods meeting to review 2.5-year overall survival data from the Phase 2b OST-HER2 trial in pul

Highlights from the CHMP July 2026 Meeting are out! Six oncology calls came out of the July CHMP meeting. Below are the key takeaways: 1) ADCs own the front line. 👉 Enhertu and Trodelvy both cleared first-line metastatic breast settings in combination. 2) Breast cancer is where the density is. 👉 All three positive opinions are in the Breast Cancer space 3) A met endpoint is not an EU approval. 👉 POTOMAC succeeded, and the FDA approved. CHMP still questioned the benefit-ris

02/08/2026 AstraZeneca and Bristol Myers Squibb Explore $400B Mega-Merger AstraZeneca and Bristol Myers Squibb Explore $400B Mega-Merger (Ref) AstraZeneca and Bristol Myers Squibb are engaged in discussions over a potential $400 billion merger, which would rank among the largest corporate deals in history Strategic Context: Bristol Myers has pursued aggressive acquisitions in the past, notably Medarex, which expanded its oncology pipeline AstraZeneca’s valuation has surged un

01/08/2026 Dr. Reddy’s secures US FDA approval for rituximab biosimilar, expanding its global oncology portfolio with Fresenius Kabi as exclusive US partner Dr. Reddy’s secures US FDA approval for rituximab biosimilar, expanding its global oncology portfolio with Fresenius Kabi as exclusive US partner (Ref) Dr. Reddy’s Laboratories received US FDA approval for its rituximab biosimilar (reference product: Rituxan®), a chimeric monoclonal antibody targeted against the pan-B-cel

28/07/2026 Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma FDA clears path for registrational Phase 2 of CLN-049 in AML Insilico Medicine's ISM6331 Earns US FDA Fast Track Designation for Advanced Mesothelioma Ris‑Rez achieves landmark Phase III PFS benefit in relapsed osteosarcoma (Ref) GSK's licensing partner Hansoh Pharma reported that its ARTEMIS-011 phase III trial of risvutatug rezetecan (Ris-Rez; B7-H3-targeted ADC) met the primary endpoint of

27/07/2026 Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met Philogen resubmits EMA application for Nidlegy with extended Phase III data CG Oncology Publishes Pivotal Phase 3 BOND-003 Cohort C Results in The Lancet Oncology Sone‑Ve delivers statistically significant OS benefit in CLDN18.2‑positive gastric/GEJ cancers, while PFS endpoint was not met (Ref) AstraZeneca's Phase 3 CLARITY-Gastric01 trial

22/07/2026 Ivonescimab plus chemotherapy delivers consistent overall survival gains across Western and Asian NSCLC patients, reinforcing FDA‑filed Phase III HARMONi data US FDA grants Priority Review for talazoparib + enzalutamide in HRR‑mutated mCSPC, with a decision expected in Q4 2026 US FDA Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer GSK's Jideytro (zidesamtinib) Gets US FDA Approval for ROS1-Positive Lung Cancer Ivonescimab plus chemot

20/07/2026 US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer US FDA Grants Tentative Approval for NATCO’s Generic Olaparib US FDA Fast Track Designation Secured for Pelareorep in Advanced Anal Cancer (Ref) Oncolytics Biotech's Pelareorep (double-stranded RNA immunotherapy), in combination with a checkpoint inhibitor, received Fast Track designation for second-line and later squamous cell carcinoma of the anal canal (SCAC) patients who progressed aft

14/07/2026 FDA frants Fast Track Designation to SOTIO’s SOT109 (CDH17-targeting) ADC for advanced Colorectal Cancer FDA grants full approval to selpercatinib for RET fusion positive solid tumors AstraZeneca secures global rights to Zegfrovy, first oral EGFR exon 20 NSCLC therapy, in $600M upfront deal with Dizal In a Ph3 trial, HBI-8000 + nivolumab improved PFS vs nivolumab + placebo, for advanced Melanoma FDA approved first generics of Gilotrif (afatinib) for EGFR‑mutant and

10/07/2026 FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance Risvutatug Rezetecan delivered first Phase III overall survival benefit vs topotecan, in relapsed small cell lung cancer FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance (Ref) Elevar Therapeutics announced on that the FDA declined to approve its combination therapy of rivoceranib (VEGFR TKI) and camrelizumab (anti–PD-1) as a first-line trea