08/10/2026 US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR Colon Cancer Perspective therapeutics receives US FDA Fast Track Designation for [212Pb]PSV359 in Solitary Fibrous Tumors US FDA granted Fast Track Designation to VIR-5500 in mCRPC China NMPA approves Enhertu as adjuvant therapy for HER2-positive early breast cancer and Datroway for metastatic TNBC US FDA approved atezolizumab + chemotherapy for adjuvant treatment of stage III dMMR

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

18/09/2026 US FDA approves Inluriyo + Verzenio for ESR1-Mutated ER+/HER2− Metastatic Breast Cancer Japan Approves Keytruda SC, Expanding Global Commercialization of Alteogen's ALT-B4 Platform Amneal Announces US FDA Approval and Launch of Lanreotide Injection US FDA approves Inluriyo + Verzenio for ESR1-Mutated ER+/HER2− Metastatic Breast Cancer (Ref) Eli Lilly announced that the U.S. FDA has granted full approval to Inluriyo (imlunestrant; estrogen receptor antagonist) + Ver

16/09/2026 Daiichi Sankyo Secures Japan Approvals for Enhertu and Datroway in First-Line Breast Cancer OncoC4 Receives US FDA Fast Track Designation for Cesalatamig in NSCLC Daiichi Sankyo Secures Japan Approvals for Enhertu and Datroway in First-Line Breast Cancer (Ref) Daiichi Sankyo announced the approval of two antibody-drug conjugates in Japan, expanding their use into the first-line metastatic breast cancer setting The approvals include Enhertu (trastuzumab deruxtecan)

September 2nd Week, 2026 Regulatory Events 🎯 The US FDA granted Accelerated Approval to Bayer’s sevabertinib (HYRNUO; mutant HER2 TKI) for the 1L Tx of HER2-mutant nsq-NSCLC with HER2/ERBB2 tyrosine kinase domain activating mutations (Ref1) ❓ How is sevabertinib positioned in NSCLC Tx landscape? 🎯 The US FDA extended the review period for Exelixis' zanzalintinib (multi-TKI) + Roche's atezolizumab (Tecentriq; anti-PD-L1) NDA for pretreated MSS CRC by 3 months, resulting i

September 1st Week, 2026 Regulatory Events 🎯 The US FDA granted an accelerated approval to AstraZeneca's camizestrant (Etcamah; SERD and complete ER antagonist) + a CDK4/6 inhibitor for the 1L Tx of HR+/HER2- ESR1-mutated LA/M breast cancer (Ref1) ❓ What is the addressable market size for Etcamah in the US? 🎯 AstraZeneca and Daiichi Sankyo' trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab (anti-HER2) has secured EU approval as 1L Tx for HER2+ unresectable or met

04/09/2026 US FDA grants accelerated approval for camizestrant combination as first-line treatment of ESR1-mutated advanced ER+ Breast cancer US FDA grants accelerated approval for camizestrant combination as first-line treatment of ESR1-mutated advanced ER+ Breast cancer (Ref) AstraZeneca announced that the US FDA has granted accelerated approval for Etcamah (camizestrant; next-generation oral SERD and complete ER antagonist) in combination with a CDK4/6 inhibitor for first-

August 4th Week, 2026 Regulatory Events 🎯 The US FDA has approved Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.' zanidatamab-hrii (Ziihera; biparatopic HER2 BsAb) + fluoropyrimidine- and platinum-containing chemo ± BeOne's tislelizumab-jsgr (Tevimbra; anti-PD-1) for the first-line Tx of adults with HER2+ advanced gastroesophageal adenocarcinoma (GEA) (Ref1) ❓ How is the approval expected to impact the GEA Tx paradigm? 🎯 The EC has approved Gilead Sciences’s

26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

August 3rd Week, 2026 Special Designations ⭐ The US FDA granted a Fast Track Designation to 858 Therapeutics' ETX-19477 (PARG inhibitor) for the Tx of adults with BRCA‑mutated, HR+/HER2‑ unresectable or metastatic breast cancer (Ref1) ❓ Who are the key competitors to ETX-19477 in the BRCA-m HR+/HER- BC? ⭐ The US FDA granted FTD to BlossomHill Therapeutics, Inc.’s BH-30643 (macrocyclic OMNI-EGFR™ inhibitor) for the Tx of adults with advanced or metastatic EGFR C797S-posit

18/08/2026 BH-30643 earns US FDA Fast Track designation for pretreated NSCLC FDA Endorses Registrational Path for Pelareorep in RAS‑Mutant MSS Colorectal Cancer PLN-101095 Secures US FDA Fast Track for ICI-Refractory Solid Tumors US FDA Grants Fast Track to ETX‑19477, a Novel PARG Inhibitor for BRCA‑Mutated Breast Cancer BH-30643 earns US FDA Fast Track designation for pretreated NSCLC (Ref) BlossomHill Therapeutics announced that its investigational drug BH-30643, a macrocyc

June 4th Week, 2026 Regulatory Updates 🎯 Pfizer's palbociclib (Ibrance; CDK4/6 inhibitor) has been approved in the US for use with trastuzumab (anti-HER2) ± pertuzumab (anti-HER2), and endocrine therapy as 1L maintenance Tx for HR+, HER2+ LA/M breast cancer following induction therapy (Ref 1) ❓ How is Ibrance positioned in the BC market landscape? 🎯 The US FDA approved Gilead Sciences’ sacituzumab govitecan-hziy (Trodelvy; TROP2 ADC) for the 1L Tx of unresectable LA/M TNB

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

02/06/2026 FDA accepts NDA and grants priority review to Roche’s giredestrant for early-stage ER+, HER2- breast cancer Candel’s CAN‑2409 Phase 3 in localized prostate cancer shows significant DFS benefit with favorable safety, supporting BLA filing in Q4 2026 Cycle Pharma secures FDA approval for CAVHANZA™, the first nilotinib ODT eliminating PPI/H₂RA timing restrictions to broaden Ph+ CML treatment flexibility FDA accepts NDA and grants priority review to Roche’s giredestran

21/05/2026 Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma Kelun-Biotech's Phase III sac-TMT Trial meets Primary PFS Endpoint in First-Line Advanced TNBC Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma (Ref) China’s NMPA approved toripalimab + disitamab vedotin for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC)

15/05/2026 FDA approved ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of neoadjuvant and adjuvant HER2+ early breast cancer UGN-103 delivers 94.5% six‑month durability in Phase 3 UTOPIA trial, with NDA submission planned for Q3 2026 to advance next‑generation RTGel therapy in recurrent LG‑IR‑NMIBC In Ph3 trial, Regeneron’s fianlimab + cemiplimab showed numeric PFS gain but missed statistical significance vs pembrolizumab in advanced or metastatic Melanoma CAN‑24

April 5th Week, 2026 Regulatory Events 🎯 The EC granted approval to Henlius’ pertuzumab biosimilar (anti-HER2; POHERDY) for HER2+ early and metastatic breast cancer (Ref 1) ❓ Which are the other key pertuzumab biosimilars in the EU market? 🎯 The US FDA accepted the sBLA and granted priority review to Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.' zanidatamab (HER2-directed BsAb) + chemotherapy ± BeOne Medicines' tislelizumab (anti-PD-1) for the first-line trea

27/04/2026 Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDU

09/04/2026 NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer (Ref) The New Drug Application (NDA) for DualityBio and BioNTech's DB-1303/BNT323 (Trastuzumab Pamirtecan, T-Pam; HER2‑targeted ADC) has been accepted by China’s National Medical Products Administ

March 2nd Week, 2026 Regulatory Events 🎯 The EC has approved an indication extension for Johnson & Johnson Innovative Medicine's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone in combination with androgen deprivation therapy, for the treatment of patients with metastatic hormone-sensitive prostate cancer and BRCA1/2 mutations (germline and/or somatic). (Ref 1) ❓ How do the outcomes of this regimen compare against the other appr