Oncology

FDA committee recommends BMS-2seventy’s Abecma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.

Tubulis secures $138.8m to develop ADCs for solid tumours

Tubulis has secured €128m ($138.8m) in a Series B2 financing round to expedite the clinical development of its antibody drug conjugates (ADCs) pipeline, focused on solid tumours.

FDA grants orphan drug status to Poseida’s multiple myeloma therapy

Poseida Therapeutics has received the US Food and Drug Administration’s (FDA) orphan drug designation for its new chimeric antigen receptor (CAR)-T therapy candidate, P-BCMA-ALLO1, to treat multiple myeloma.

iOnctura receives orphan drug status for pancreatic cancer therapy

iOnctura has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its autotaxin inhibitor, cambritaxestat, for pancreatic cancer.

UK NICE recommends GSK’s Dostarlimab regimen for womb cancer

The UK National Institute for Health and Care Excellence (NICE) has recommended GSK’s Dostarlimab, marketed as Jemperli, for use with chemotherapy in treating specific advanced or recurrent womb cancers.

EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.

SN Bioscience’s SNB-101 received FDA orphan drug designation

The US Food and Drug Administration (FDA) has granted orphan drug designation to SN Bioscience's SNB-101, a polymer nanoparticle anticancer drug to potentially treat pancreatic cancer.

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive opinion for the Janssen Pharmaceutical Companies of Johnson & Johnson’s CARVYKTI (cilta-cel) for earlier stage of relapsed and refractory multiple myeloma (RRMM) treatment.

Japan grants priority review for Astellas’ urothelial cancer regimen

Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for Astellas Pharma’s supplemental new drug application (sNDA) for PADCEV (enfortumab vedotin) and KEYTRUDA (pembrolizumab) combination to treat urothelial cancer.