04/12/2025 BMS' Breyanzi received FDA approval for R/R MZL J & D Pharmaceuticals' investigational therapy received the FDA orphan drug designation for HCC BMS' Breyanzi received FDA approval for R/R MZL ( Ref ) The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy.  The approva

03/12/2025 Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL ( Ref ) The US FDA granted approval to Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. This approval con

26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL ( Ref ) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D

23/11/2025 NovelWise's NBM-BMX received the FDA orphan drug designation for uveal melanoma ( Ref ) The US FDA granted the orphan drug designation to NovelWise Pharmaceutical Corporation's NBM-BMX (selective HDAC8 inhibitor) for the treatment of uveal melanoma. John Soong, MD, Chief Executive Officer, NovelWise: “ Receiving both Fast Track Designation and now Orphan Drug Designation underscores NBM-BMX’s promise in addressing a high unmet medical need for patients with uveal m

21/11/2025 Pembrolizumab + enfortumab vedotin received the FDA approval for MIBC ( Ref ) The US FDA granted approval to Merck & Co./MSD pembrolizumab (anti-PD-1; both IV and SC formulations) in combination with Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) as a neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemothera

20/11/2025 Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC ( Ref ) Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. The submission is based

18/11/2025 AbbVie and Genmab's epcoritamab + rituximab + lenalidomide received FDA approval for R/R FL ( Ref ) The US FDA granted approval to AbbVie and Genmab's epcoritamab (bispecific CD20-directed CD3 T-cell engager) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).  The approval is based on results from the Phase 3 EPCORE FL-1 trial of the combo vs rituximab and lenalidomide Lorenzo Falchi, M.D.,

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC ( Ref ) The US FDA approved Regeneron...

16/09/2025 Corbus and CSPC Pharma's CRB-701 ADC received the FDA Fast Track Designation for R/M HNSCC ( Ref ) The US FDA granted the Fast...

12/09/2025 The NDA for Alphamab Oncology and CSPC Pharma's anbenitamab + chemo has been accepted by the NMPA for HER2 +ve GC/GEJC ( Ref )...

11/09/2025 Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan has been accepted for review in the EU for HER2 +ve solid tumors ( Ref...

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer ( Ref ) The US FDA granted...

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC ( Ref ) The US FDA approved Johnson & Johnson's INLEXZO™...

29/08/2025 BeOne reported positive topline results for sonrotoclax in R/R MCL ( Ref ) BeOne Medicines' Phase 1/2 BGB-11417-201 trial of...

28/08/2025 TOLREMO Therapeutics' TT125-802 received two fast track designations from the US FDA for NSCLC ( Ref ) The US FDA granted two...

26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer ( Ref ) The US FDA...

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer ( Ref ) The US FDA granted the Orphan Drug...

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma ( Ref ) The US FDA granted...

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies ( Ref ) MAIA...