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

25/11/2025 CStone Pharmaceuticals' sugemalimab received the EC approval for unresectable stage III NSCLC ( Ref ) The European Commission  granted approval to CStone Pharmaceuticals' sugemalimab (anti-PD-L1) as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 ≥1% and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy. Dr. Jason Yang, CEO, President of R&D,

20/11/2025 Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC ( Ref ) Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. The submission is based

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL ( Ref ) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.  The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmac

Highlights from the CHMP Nov 2025 Meeting are out! New Medicines 💊  Eli Lilly and Company 's imlunestrant (Inluriyo: brain-penetrant oral ERα degrader) is indicated as monotherapy for the treatment of adult patients with ER+ve, HER2-ve, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen. New Hybrid Medicines 💊  Accord Healthcare 's enzalutamide (Enzalutamide Ac

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

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC ( Ref ) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC.  Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by t

03/11/2025 Iovance's lifileucel TIL therapy elicited an ORR of 25.6% in previously treated non-sq NSCLC ( Ref ) Iovance Biotherapeutics reported interim data from its registrational Phase 2 IOV-LUN-202/NCT04614103 trial of lifileucel monotherapy (autologous TIL therapy) in patients with previously treated advanced non-squamous NSCLC without actionable genetic mutations. An ORR of 25.6% (CR: 5.1%) was achieved in a pool of 39 patients At a median follow up of 25.4 mos, the mDO

Highlights from the CHMP Oct 2025 Meeting are out! Indication Expansions 💊  Bristol Myers Squibb 's lisocabtagene maraleucel (Breyanzi; autologous CD19-directed CAR T-cell therapy) is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor 💊  CStone Pharmaceuticals  and  Ewopharma 's sugemalimab (Cejemly; anti-PD-L1) as monotherapy i

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...

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA ( Ref ) China's NMPA has accepted Sichuan...

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC ( Ref ) Nuvalent, Inc has completed its NDA...

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...

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...

15/09/2025 Daiichi and Merck's raludotatug deruxtecan received the Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or...