Drug Filing

FDA grants priority review to Genentech’s Tecentriq as first-line treatment of certain people with advanced NSCLC

Genentech, a member of the Roche Group, said that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing.

Merck receives complete response letter from FDA for sBLAs for KEYTRUDA six-week dosing schedule

Merck said that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding its supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.

PharmaMar, Jazz get FDA priority review for lurbinectedin in relapsed SCLC

PharmaMar and Jazz Pharmaceuticals have secured priority review for their synthetic compound lurbinectedin from the US Food and Drug Administration (FDA) for its use in relapsed small cell lung cancer (SCLC).

Ascletis’ IND filing for its NASH drug accepted by NMPA

Ascletis Pharma announces the application for in-house developed Category 1 Drug ASC41 for clinical trials of NASH indication has been accepted by China's National Medical Products Administration (NMPA).

Epizyme seeks FDA accelerated approval for Tazverik to treat follicular lymphoma

Epizyme is seeking accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat patients with relapsed or refractory follicular lymphoma (FL).

Seattle Genetics gets FDA priority review for tucatinib in locally advanced or metastatic HER2-positive breast cancer

Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Company’s New Drug Application (NDA) for the investigational medicine tucatinib.

The US FDA accepts for priority review Bristol-Myers Squibb’s BLA for liso-cel for adult patients with relapsed or refractory large B-cell lymphoma

Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

Deciphera Pharmaceuticals announces US FDA acceptance of NDA and priority review for ripretinib in patients with advanced gastrointestinal stromal tumours

Deciphera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).

Novartis’ capmatinib gets FDA priority review in METex14 mutated advanced NSCLC

Novartis has secured priority review for its MET inhibitor capmatinib (INC280) from the US Food and Drug Administration (FDA) for the treatment of a type of non-small cell lung cancer (NSCLC).