Oncology

FDA to review Regeneron’s linvoseltamab BLA for multiple myeloma treatment

The US Food and Drug Administration (FDA) has accepted to review Regeneron Pharmaceuticals’ resubmitted biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory (R/R) multiple myeloma (MM).

AdvanCell, Lilly partner on new targeted alpha therapies for cancer treatment

Radiopharmaceutical company AdvanCell has expanded its partnership with Eli Lilly and Company to advance targeted alpha therapies for the treatment of cancer.

FDA clears Auron’s AUTX-703 IND to treat haematological malignancies

The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of Auron Therapeutics’ oral KAT2A/B degrader, AUTX-703, allowing it to progress through clinical development for haematological malignancies.

EMA’s CHMP recommends approval of Bristol Myers Squibb’s HCC treatment combo

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) in adults.

Manas AI launches to focus on cancer medicine discovery

Manas AI has officially launched for transforming new cancer medicines discovery.

FDA clears Axcynsis’ AT03-65 IND for CLDN6-positive solid tumours

The US Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) of Axcynsis Therapeutics’ antibody-drug conjugate (ADC), AT03-65, targeting CLDN6-positive solid tumours.

JW Therapeutics’ Carteyva receives breakthrough therapy status for r/r LBCL

JW Therapeutics has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for Carteyva (relmacabtagene autoleucel injection) to treat relapsed or refractory large B-cell lymphoma (r/r LBCL).

FDA grants priority review to Dizal’s sunvozertinib NDA for NSCLC treatment

The US Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.

China’s NMPA approves Astellas’ advanced gastric cancer combo therapy

The China National Medical Products Administration (NMPA) has granted approval to Astellas Pharma’s VYLOY (zolbetuximab), a first-in-class monoclonal antibody, for use in conjunction with chemotherapy for the first-line treatment of individuals with a specific type of gastric cancer.