Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
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The FDA has been granted to Pemfexy™ (pemetrexed for injection; Eagle Pharmaceuticals), an alternative to Alimta® (Eli Lilly), for the treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma.
Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are rare diseases that are generally specific to the lungs, kidneys and upper airways.
The median OS was not reached at the time of the data cut-off in the pembrolizumab plus chemotherapy arm and was 11.3 months for those in the chemotherapy arm.
Data showed that 12% responded to treatment based on assessment by a Blinded Independent Central Review, regardless of PD-L1 expression; 11% had a partial response, and 1 patient had a complete response (0.9%).
The sBLA is based on results from the Phase 2 KEYNOTE-224 trial, which enrolled 104 individuals with advanced hepatocellular carcinoma previously treated with sorafenib who were either intolerant to or showed progression of disease after treatment.
Dacomitinib is a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
REACH-2 was a randomized, double-blind, placebo-controlled trial that enrolled 292 patients with hepatocellular carcinoma (HCC) who were intolerant to, or had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High) defined as AFP ≥400ng/mL.
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to monomethyl auristatin E, a microtubule-disrupting agent.
The approval was based on evidence from animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data which demonstrated Mvasi is a biosimilar to Avastin.