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

Highlights from the CHMP June 2026 Meeting are out! New Biosimilar Medicines 💊 Ascend GmbH & Enzene Biosciences Ltd's denosumab (Denosumab Ascend; anti-RANKL) is intended for the prevention of bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity Indication Expansions 💊 AstraZenec

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

30/06/2026 BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL (Ref) BeOne Medicines announced that BRUKINSA (zanubrutinib; BTK inhibitor) combined with rituximab met the primary progression-free survival endpoint in the Phase 3 MANGROVE

29/06/2026 Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial Samsung Bioepis’ Keytruda biosimilar SB27 demonstrates Phase 1 and Phase 3 equivalence in NSCLC trials MHRA validates Eisai and Nuvation Bio's taletrectinib MAA in UK, expanding ROS1+ NSCLC access Genmab & AbbVie's epcoritamab + lenalidomide combination meets primary endpoint of PFS in Phase 3 DLBCL trial (Ref) Genmab announced positive topline results from

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

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

22/06/2026 Exelixis’ STELLAR-303 trial showed OS benefit in ITT, non‑significant trend in NLM in mCRC; FDA decision due Dec 2026 SystImmune secures world’s first bispecific ADC approval with iza-bren in China CARsgen secures NMPA approval for satri-cel, the world’s first CAR-T therapy in solid tumors, targeting Claudin18.2-positive advanced gastric cancer Sigvotatug vedotin in metastatic non-squamous NSCLC missed OS in the overall population but showed promising efficacy in s

18/06/2026 US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL US FDA accepts Roche’s sBLA for subcutaneous Lunsumio + Polivy in relapsed/refractory LBCL (Ref) The US FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for subcutaneous Lunsumio VELO (mosunetuzumab; CD20xCD3 T-cell engaging bispecific antibody) + Polivy (polatuzumab vedotin; CD79b targeting antibody-drug conjugate) in adults with relapsed/refractory

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

16/06/2026 US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer US FDA grants Fast Track to givastomig, in first‑line HER2‑negative metastatic gastric cancer (Ref) ABL Bio & NovaBridge's givastomig, a CLDN18.2 x 4-1BB bispecific antibody, received Fast Track status in combination with nivolumab and chemotherapy for first-line HER2-negative advanced/metastatic gastroesophageal adenocarcinomas that are CLDN18.2 and PD-L1 positive Clinica

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

14/06/2026 Eli Lilly's Jaypirca Cuts Disease Progression Risk by 45% in Previously Treated CLL/SLL Eli Lilly's Jaypirca Cuts Disease Progression Risk by 45% in Previously Treated CLL/SLL (Ref) Eli Lilly announced positive Phase 3 BRUIN CLL-322 results for Jaypirca (pirtobrutinib) combined with venetoclax and rituximab in relapsed/refractory CLL/SLL, meeting its primary endpoint with a statistically significant 45% reduction in disease progression or death compared to venetocl

12/06/2026 Jazz Pharmaceuticals' Zepzelca Phase 3 LAGOON Trial Misses Primary Endpoint in Second-Line SCLC AbbVie's Venetoclax Shows Sustained 9-Year Efficacy in First-Line CLL at EHA 2026 Jazz Pharmaceuticals' Zepzelca Phase 3 LAGOON Trial Misses Primary Endpoint in Second-Line SCLC (Ref) The Phase 3 LAGOON trial, evaluating Zepzelca (lurbinectedin) in relapsed/second-line metastatic small cell lung cancer (SCLC), did not meet its primary endpoint of overall survival (OS) fo

11/06/2026 FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer Alembic wins tentative USFDA approval for Larotrectinib capsules FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer (Ref) The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) and granted priority review for Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chem

June 1st Week, 2026 Regulatory Updates 🎯 Australia’s Therapeutic Goods Administration (TGA) has conditionally approved Iovance Biotherapeutics, Inc.'s lifileucel (Amtagvi®; tumor infiltrating lymphocytes), making it the first T cell therapy for a solid tumor and the first treatment option in Australia for advanced melanoma in adults, after anti‑PD‑1 and targeted therapy (Ref) ❓ Which other regimens have the potential to challenge lifileucel in this setting? 🎯 The U

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

09/06/2026 Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref) Imugene's Azer-cel (azercabtagene zapreleucel; CD1