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

26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutat

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer (Ref) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults with

04/11/2025 Merck and Blackstone enter into a $700M R&D funding agreement for Sacituzumab Tirumotecan (Ref) Merck & Co./MSD entered into an agreement to receive funds managed by Blackstone Life Sciences for the development of sacituzumab tirumotecan (sac-TMT; TROP2 ADC). Under the terms of the agreement, Blackstone will pay Merck $700 million (which is non-refundable, subject to termination provisions provided for in the agreement) to fund a portion of the development costs fo

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies (Ref) The US FDA accepted Orca Bio's BLA seeking approval for Orca-T (allogeneic T-cell immunotherapy) as a treatment for hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. Priority Review status has been granted with a PDUFA target action date of April 6, 2026 The BLA submission was based on positive resul

07/08/2025 ProteinQure's PQ203 received the Fast track designation for TNBC (Ref) The US FDA granted the Fast Track designation to ProteinQure's PQ203 (SORT1 targeting peptide drug conjugate) for the treatment of patients with triple negative breast cancer. ProteinQure also received regulatory clearance from both the US FDA and Health Canada to initiate a Phase 1 trial evaluating the safety, pharmacokinetics, pharmacodynamics and anti-cancer activity of PQ203 The Phase 1 stud