30/06/2026 BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL (Ref) BeOne Medicines announced that BRUKINSA (zanubrutinib; BTK inhibitor) combined with rituximab met the primary progression-free survival endpoint in the Phase 3 MANGROVE

17/06/2026 Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception Avenacy Launches Bortezomib for Injection in the U.S., Marking Its 28th Product Since Inception (Ref) Avenacy has officially launched Bortezomib for Injection in the US, a generic equivalent of VELCADE® indicated for adults with multiple myeloma and mantle cell lymphoma The product is available as a 3.5 mg single-dose vial and features Avenacy's differentiated packaging

26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL (Ref) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D,

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 Accord

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 is indi

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

29/08/2025 BeOne reported positive topline results for sonrotoclax in R/R MCL (Ref) BeOne Medicines' Phase 1/2 BGB-11417-201 trial of sonrotoclax (BCL2 inhibitor) met its primary endpoint of ORR in adult patients with relapsed/refractory mantle cell lymphoma following treatment with a BTK inhibitor and anti-CD20 therapy. Promising results were also observed across several secondary efficacy endpoints, including CR, DOR and PFS The safety profile was generally well-tolerated,

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (Ref) The US FDA granted accelerated approval to Jazz Pharmaceuticals' Modeyso™ (dordaviprone; oral antagonist of dopamine receptor D2 and agonist of ClpP) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Contin