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

23/06/2026 EC approves Trodelvy (sacituzumab govitecan) monotherapy as first-line Tx for metastatic triple-negative breast cancer patients ineligible for PD-(L)1 therapy EC approves Trodelvy (sacituzumab govitecan) monotherapy as first-line Tx for metastatic triple-negative breast cancer patients ineligible for PD-(L)1 therapy (Ref) Gilead Sciences announced that the European Commission granted marketing authorization for sacituzumab govitecan-hziy (Trodelvy; Trop-2-directed

08/06/2026 Zai Lab secures China NMPA approval for TIVDAK®, the first ADC for recurrent/metastatic cervical cancer Merck & Gilead halt Phase 3 KEYNOTE-D46/EVOKE-03 trial as Trodelvy + Keytruda fails to show statistically significant survival benefit in first-line PD-L1–high NSCLC Zai Lab secures China NMPA approval for TIVDAK®, the first ADC for recurrent/metastatic cervical cancer (Ref) China’s NMPA approved TIVDAK® (tisotumab vedotin) for adult patients with recurrent or me

20/04/2026 Arcus halts Lung Cancer Trial With Gilead After Futility Analysis FDA granted Fast Track designation for Lunresertib + Zedoresertib in Platinum-Resistant Ovarian Cancer FDA Grants Orphan Drug Status to Orion’s ODM-212 for Mesothelioma FDA Grants Priority Review for PADCEV + Keytruda in Muscle-Invasive Bladder Cancer Arcus halts Lung Cancer Trial With Gilead After Futility Analysis (Ref) Arcus Biosciences has halted its Phase 3 lung cancer trial with Gilead Sciences

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 sy

21/08/2025 In a $350M deal, Kite to acquire Interius BioTherapeutics (Ref) Kite (a Gilead Company) entered into a definitive agreement to acquire Interius BioTherapeutics developing in vivo CAR therapeutics for $350 million. Interius’ off-the-shelf and personalized approach is designed to be delivered via a single IV infusion, eliminating the need for preconditioning chemotherapy and complex cell processing Under the terms of the agreement, Kite will acquire all of the outsta

April 4th Week, 2025 Regulatory & Market News 🎯 Akeso Biopharma’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for the Tx of previously untreated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (nkNPC). 👉 The FDA also approved single agent penpulimab-kcqx for the Tx of nkNPC patients who have progressed following platinum chemo and at least one other prior line of therapy. (Ref 1) ❓ How does this approval affect the current Tx landscape