Accelerated Approval

Accelerated Approval

A regulatory mechanism developed by the US FDA to make new drug products available for serious or life threatening diseases when they appear to provide a benefit over available therapy—or when there is no effective treatment.
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M2 EQUITYBITES-August 20, 2019-US FDA agrees to PharmaMar's proposal to file for accelerated approval of New Drug Application for lurbinectedin in monotherapy
M2 PHARMA-August 20, 2019-US FDA agrees to PharmaMar's proposal to file for accelerated approval of New Drug Application for lurbinectedin in monotherapy
The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
The FDA has also granted accelerated approval to Rozlytrek for the treatment of adults and children over 12 with neurotrophic tyrosine receptor kinase gene fusion-positive solid tumours.
The US Food and Drug Administration (FDA) on Thursday granted accelerated approval for Rozlytrek (entrectinib) for the treatment of patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.
Tecentriq has accelerated approval from the FDA for the treatment of adults with locally advanced or mUC, including those who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1--stained tumor-infiltrating immune cells covering [greater than or equal to]5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
Cancer drugs are usually granted accelerated approval in the hopes of providing patients faster access to medicine that could save their lives.
NORDIC BUSINESS REPORT-May 21, 2019-Oncopeptides applies for accelerated approval of melflufen in the US
Alimta in combination with pembrolizumab and carboplatin was first approved in June under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC, based on tumor response rates and PFS data from the Phase 2 study Keynote-021 (Cohort G1).
THE FOOD AND DRUG Administration has granted accelerated approval for pembrolizumab (Keytruda) for the treatment of pediatric and adult Merkel cell carcinoma, specifically for recurrent locally advanced or metastatic disease.
Food and Drug Administration granted accelerated approval to Cranbury-based Amicus Therapeutics for Galafold, an oral treatment for adults with Fabry disease.The U.S.
Therapeutics were often designated as orphan products (65.2 percent) and qualified for FastTrack review and Accelerated Approval (52.2 and 39.1 percent, respectively).
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