Oncology

FDA grants fast track designation for Elevation Oncology’s EO-3021

The US Food and Drug Administration (FDA) has granted fast track designation for Elevation Oncology’s EO-3021, a treatment for patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer.

EMA CHMP recommends AbbVie’s mirvetuximab soravtansine for ovarian cancer

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AbbVie’s mirvetuximab soravtansine in adults with a specific type of ovarian cancer.

Bayer partners with NextRNA to develop lncRNA-targeting cancer therapies

Bayer has announced a strategic partnership with NextRNA Therapeutics to develop long non-coding RNAs (lncRNAs)-targeting small molecule therapeutics for cancer treatment.

Zuellig Pharma and Regeneron sign deal to supply Libtayo in South Korea and Taiwan

Zuellig Pharma has entered into an exclusive distribution agreement with Regeneron Ireland DAC for the launch and commercialisation of Libtayo (cemiplimab) in the South Korean and Taiwanese markets.

GSK’s B7-H3-targeted ADC receives FDA breakthrough therapy status

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GSK's investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK'227).

FDA grants RMAT designation to AffyImmune’s AIC100 for thyroid cancer

The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for AffyImmune’s CAR T-cell therapy, AIC100, to treat recurrent anaplastic thyroid cancer (ATC).

Amneal Pharmaceuticals launches ready-to-use injectable FOCINVEZ

US-based Amneal Pharmaceuticals has announced the launch of FOCINVEZ, a ready-to-use injectable for the prevention of nausea and vomiting in chemotherapy patients.

Adicet Bio’s ADI-270 receives FDA Fast Track Designation for kidney cancer treatment

The US Food and Drug Administration (FDA) has granted Fast Track Designation to Adicet Bio's ADI-270, a potential treatment for patients suffering with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have received treatment with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.

EU approves AstraZeneca’s Tagrisso combined with chemotherapy for EGFRm NSCLC

The European Commission has approved AstraZeneca's Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.