Oncology

Novartis gets positive CHMP opinion for Kisqali in early breast cancer

Novartis has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for Kisqali (ribociclib) as an adjuvant treatment for certain early breast cancer patients.

FDA grants priority review for AstraZeneca’s Calquence sNDA

The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

FDA grants fast track status for Volastra’s VLS-1488 to treat ovarian cancer

The US Food and Drug Administration (FDA) has granted fast track designation for Volastra Therapeutics’ KIF18A inhibitor, VLS-1488, to treat patients with platinum-resistant high-grade serous ovarian cancer (HGSOC).

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).