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 ap

March 1st Week, 2026 Regulatory Events 🎯 The European Commission approved Incyte ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal. (Ref 1) ❓ How do the outcomes of this regimen compare against the current SOC? 🎯 The US FDA approved Johnson & Johnson Innovative Medicine ’s teclistamab (BCMA-directed CD3 T-cell engager) + daratu

November 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson 's Darzalex Faspro (daratumumab, an anti-CD38, and hyaluronidase) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of this indication? Clinical Events 🔬 In the registrational cohort of the Phase 2 IOV-LUN-202/NCT04614103 trial, Iovance Biotherapeutics, Inc. ’s lifileuc

August 1st Week, 2025 Regulatory Events 🎯 AbbVie submitted a sNDA to the US FDA for AbbVie and Roche ’s venetoclax (BCL-2...

July 1st Week, 2025 Regulatory Updates 🎯 The US FDA granted accelerated approved for Dizal Pharmaceutical ’s sunvozertinib (EGFR TKI)...

Dear Readers, Welcome to our inaugural CGT Watch newsletter! We’re excited to bring you monthly highlights on novel targets, innovative...