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

07/07/2026 ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety ITM‑11 significantly outperforms everolimus in advanced GEP‑NETs with superior efficacy and safety (Ref) ITM announced that primary results from its Phase 3 COMPETE trial were published in The Lancet, showing that investigational ¹⁷⁷Lu-edotreotide (ITM-11; SSTR2-targeted peptide receptor radionuclide therapy) significantly improved progression-free survival and respon

02/07/2026 Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial Roche's Divarasib demonstrates superiority over approved KRAS G12C Inhibitors in Phase 3 NSCLC trial (Ref) Roche's Phase 3 Krascendo 1 study of divarasib (next-generation KRAS G12C inhibitor) demonstrated statistically significant improvements in both progression-free and overall survival vs approved first generation KRAS G12C inhibitors sotorasib or adagrasib in pa

26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

24/06/2026 US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (TNBC) EU approves KEYTRUDA + Padcev as first PD-1 + ADC perioperative regimen for cisplatin-ineligible MIBC IBRANCE secures US FDA approval as the first CDK4/6 inhibitor for HR+, HER2+ metastatic breast cancer maintenance US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizu

17/06/2026 Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception (Ref) Avenacy has officially launched Bortezomib for Injection in the US, a generic equivalent of VELCADE® indicated for adults with multiple myeloma and mantle cell lymphoma The product is available as a 3.5 mg single-dose vial and features Avenacy's differentiated packaging

15/06/2026 Midstage Pancreatic Cancer Study Fails to Meet Primary Endpoint but Will Advance to Phase 3 FDA accepts ozekibart BLA, setting April 2027 PDUFA for conventional Chondrosarcoma Halia Therapeutics Secures FDA Fast Track Designation for Ofirnoflast in Lower-Risk MDS Menarini Group's Phase 3 SENTRY trial met its first co-primary endpoint, with the selinexor + ruxolitinib combination achieving significant improvement in spleen volume reduction (SVR35) vs ruxolitinib alo

03/06/2026 Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26 Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC Amtagvi® (lifileucel) wins conditional TGA approval as