November 4th Week, 2025 Regulatory Events 🎯 The EC granted approval to Bristol Myers Squibb 's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to AstraZeneca ’s neoadjuvant durvalumab (anti-PD-L1) + ch

November 3rd Week, 2025 Regulatory Events 🎯 The EC granted approval to Merck & Co./ MSD 's subcutaneous formulation of pembrolizumab (KEYTRUDA SC, anti-PD-1) for use across all 33 KEYTRUDA indications for adult patients in Europe. (Ref 1) ❓ What are the key pros and cons of this SC formulation? 🎯 The EC granted approval to Regeneron 's cemiplimab (anti-PD-1) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after

November 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted full approval to Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. 's ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval expected to impact the Tx algorithm of AML? Clinical Events 🔬 In the Phase 3 PEAK trial, Cogent Biosciences ' bezuclastinib (KIT inhibitor) + sunitinib met the prim

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

October 5th Week, 2025 Regulatory Events 🎯 The EC approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of LA SCCHN? Clinical Events 🔬 Merck & Co./ MSD and Eisai US reported that the Phase 3 LITESPARK-011 trial of b

October 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Regeneron 's cemiplimab (PD-1 inhibitor) as an adjuvant Tx for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm of this indication? 🎯 The US FDA accepted for Priority Review Orca Bio 's BLA seeking approval of Orca-T (allogeneic T-cell immunotherapy) as a Tx of hematological malignanci

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Jazz Pharmaceuticals ' lurbinectedin (DNA alkylating agent) + Roche 's...

September 4th Week, 2025 Regulatory Events 🎯 The US FDA approved Eli Lilly and Company 's imlunestrant (oral estrogen receptor...

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD ’s Keytruda Qlex (subcutaneous injection of...

September 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Johnson & Johnson Innovative Medicine 's INLEXZO (TAR-200; gemcitabine...

September 1st Week, 2025 Regulatory Events 🎯 China’s NMPA approved Boehringer Ingelheim ’s zongertinib (HER2-selective tyrosine kinase...

August 4th Week, 2025 Regulatory Events 🎯 The EC approved BeOne Medicines ' tislelizumab (anti-PD-1) + platinum-containing chemo as...

August 4th Week, 2025 Regulatory Events 🎯 Health Canada issued a NOC/c for Iovance Biotherapeutics, Inc. 's lifileucel (autologous...

August 3rd Week, 2025 Regulatory Events 🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

August 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Boehringer Ingelheim 's zongertinib (kinase...

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

July 4th Week, 2025 Regulatory Events 🎯 The EC approved Bayer and Orion Pharma ’s darolutamide (androgen receptor inhibitor) +...

July 3rd Week, 2025 Regulatory Updates 🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol...

July 2nd Week, 2025 Regulatory Updates 🎯 The EC approved BeOne Medicines ' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the...

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