Category PRECISION MEDICINE

Precision Medicine Trials and Molecular Testing Guidelines Expand to Reach More Patients

The Lung Cancer Master Protocol (Lung-MAP), a large precision medicine umbrella trial supported by the National Cancer Institute (NCI) and their partners, has opened the trial to include advanced-stage patients with all non–small cell lung cancers (NSCLCs). To accommodate these new trial patients, the NCI has also made further changes to the trial’s protocol.  The

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Sarepta Duchenne drug rejected by FDA in surprise setback

In an unexpected decision, the Food and Drug Administration rejected Sarepta Therapeutics’ experimental drug for Duchenne muscular dystrophy, issuing on Monday a Complete Response Letter to the rare disease biotech.  According to Sarepta, the agency cited in its refusal infection risk tied to the drug’s delivery as well as preclinical signs of kidney toxicity. Called

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FDA approves entrectinib which targets a key genetic driver of cancer, rather than a specific type of tumour

The U.S. Food and Drug Administration (FDA) today granted accelerated approval to entrectinib, a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. “We are in an exciting era of innovation in cancer treatment as we

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US FDA approves the first immunotherapy for extensive-stage small cell lung cancer

Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC) First new initial treatment option approved by the U.S. Food and Drug Administration (FDA) for people with ES-SCLC in more than 20 years Tecentriq in combination with chemotherapy

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