July 4th Week, 2025 Regulatory Events 🎯 The EC approved Bayer and Orion Pharma’s darolutamide (androgen receptor inhibitor) + androgen deprivation therapy for the Tx of metastatic hormone-sensitive prostate cancer. (Ref 1) ❓ How is this approval going to impact the Tx paradigm of mHSPC? 🎯 The EC approved Roche's inavolisib (PIK3CA inhibitor) + palbociclib + fulvestrant for the Tx of PIK3CA-mutated, ER+ve, HER2-ve, LA/M breast cancer, following recurrence on or within 12

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA (Ref) The US FDA issued a Complete Response Letter (CRL) regarding the BLA for Replimune's vusolimogene oderparepvec (RP1; herpes simplex virus engineered with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivolumab for the treatment of advanced melanoma. The CRL highlighted that the FDA was unable to approve the application in its present form due to the following reasons: The Ph1

June 4th Week,2025 Regulatory Events 🎯 Daiichi Sankyo and AstraZeneca's Dato-DXd (Datroway; TROP2 ADC) has been granted an accelerated approval by the US FDA for the Tx of EGFR+ NSCLC patients previously treated with EGFR directed therapy and platinum-based chemotherapy. (Ref 1) ❓ Which other key regimens are expected to enter this setting in the near future? Special Designations ⭐ enGene's detalimogene voraplasmid (non-viral gene therapy) was granted a Regenerative Medici

24/06/2025 Opdivo + Yervoy received supplemental approval in Japan to expand the use for unresectable hepatocellular carcinoma (Ref) Ono Pharmaceutical and Bristol-Myers Squibb K.K. have received a supplemental approval of Opdivo (nivolumab; anti-PD-1) + Yervoy (ipilimumab; anti-CTLA-4) in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC) The approval is based on the results from the global Phase 3 CheckMate-9DW trial of nivo + ipi vs i