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

14/05/2026 Alembic secures USFDA tentative nod for Darolutamide tablets, 300 mg In Ph3 VOLGA trial, durvalumab + enfortumab vedotin significantly improved EFS and OS in MIBC Celcuity expands Phase 3 VIKTORIA-2 trial to include endocrine‑sensitive HR+/HER2‑ breast cancer patients Astellas files sNDA in Japan for PADCEV + Keytruda in cisplatin‑eligible muscle‑invasive bladder cancer, backed by Phase 3 EV‑304 survival benefit Alembic secures USFDA tentative nod for Darolutamide

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

09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC (Ref)

17/12/2025 Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma (Ref) The European Commission granted

December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial of A

12/12/2025 Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers Johnson & Johnson's AKEEGA received FDA approval for BRCA2-mutated CSPC Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers (Ref) The Phase 3 STAR-221 trial of Arcus Biosciences and Gilead's domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs nivolumab + chemother

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC (Ref) Nuvalent, Inc has completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1-positive NSCLC. SOPHiA GENETICS expanded its collaboration with AstraZeneca for an optimized NGS solution (Ref) SOPHiA GENETICS and AstraZeneca announced an expansion of their collaboration from the W

14/08/2025 Halda's HLD-0915 received the Fast Track Designation from the US FDA for mCRPC (Ref) The US FDA granted the Fast Track designation to Halda Therapeutics' HLD-0915 (androgen receptor-targeting RIPTAC) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). A Phase 1/2 trial of HLD-0915 in mCRPC is ongoing to evaluate the safety, tolerability, PK, PD, and anti-tumor activity Christian Schade, President and CEO, Halda Therapeutics:

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

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC (Ref) The European Commission granted marketing authorization to Bayer and Orion Corporation’s darolutamide (Nubeqa; oral androgen receptor inhibitor) + androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer The approval was based on results from the pivotal Phase 3 ARANOTE trial in which darolutamide + ADT significantly reduced the risk of rad

July 2nd Week, 2025 Regulatory Updates 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the first-line Tx of metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. (Ref 1) ❓ What are the other key Asia-specific trials emerging in this indication? 🎯 The UK’s MHRA granted marketing authorization to ImmunityBio, Inc.'s nogapendekin alfa inbakicept-pmln (lymphocyte-stimulating agent

09/07/2025 Artera's ArteraAI Prostate received the Breakthrough Device designation from the US FDA (Ref) The US FDA granted the Breakthrough Device designation to Artera's ArteraAI Prostate (an AI precision medicine tool) intended to assist clinicians with risk-based decisions for patients with localized prostate cancer ArteraAI Prostate analyzes digital pathology images of the prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-yr risk of distant met

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients (Ref) The first patient has been dosed in the Phase 3 IDeate-Prostate01/NCT06925737 trial evaluating Daiichi Sankyo and Merck & Co./MSD's ifinatamab deruxtecan (I-DXd; B7-H3 ADC) vs docetaxel in patients with metastatic castration-resistant prostate cancer (CRPC) with disease progression during or after treatment with an androgen receptor pathway