August 4th Week, 2025 Regulatory Events 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + platinum-containing chemo as neoadjuvant Tx followed by tislelizumab monotherapy as adjuvant Tx for resectable NSCLC at high risk of recurrence. (Ref 1) ❓ How is BeOne’s regimen positioned compared to other approved perioperative options? Clinical Events 🔬 Per final analysis of the Phase 3 HARMONi-A trial, a statistically significant and clinically meaningful OS benef

Highlights from the CHMP July 2025 Meeting are out! New Medicines 💊 Servier's vorasidenib (Voranigo; IDH1/2 inhibitor) monotherapy for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy New Biosimilars 💊 Henlius' denosuma

24/07/2025 GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic cancer (Ref) The US FDA granted the Fast Track Designation to GenFleet Therapeutics and Verastem Oncology's VS-7375 (oral KRAS G12D (ON/OFF) inhibitor) for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas, and for the treatment of patients with KRAS G12D-mutated locally adva

Highlights from the CHMP May 2025 Meeting are out! ⭐ New Medicines 💊 Autolus Therapeutics' obecabtagene autoleucel (Aucatzyl; CD19 CAR-T cell therapy) for the treatment of adults from 26 years of age with R/R B cell precursor acute lymphoblastic leukaemia 👉 Positive opinion recommending the granting of a conditional marketing authorisation 💊 GSK's belantamab mafodotin (Blenrep; anti-BCMA ADC) for the treatment of adults with R/R multiple myeloma: 👉In combination with bort

Highlights from the CHMP March 2025 Meeting are out! ⭐ Indication Expansions: 💊 Pfizer's bosutinib (Bosulif; second-generation BCR-ABL TKI) use is extended to children aged 6 years and older with certain types of chronic myelogenous leukaemia, along with a new pharmaceutical form (hard capsules), associated with two new strengths (50 mg and 100 mg). 💊 AstraZeneca's acalabrutinib (Calquence; BTK inhibitor) + rituximab (anti-CD20 mAb) + bendamustine for the Tx of adult pati

PD-(L)1 axis inhibits CAR-T cell activation, proliferation, survival, and functionality. Thus, CAR-T mediated direct targeting of the PD-(L)1 immunosuppressive axis or modulation of the axis along with CAR-T therapy holds a huge promise to unleash the full potential of CAR-Ts. Multiple strategies are under investigation to target PD-(L)1 immunosuppressive axis to increase CAR-T therapy efficacy. We have grouped the strategies under the following three broad categories, Combin