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
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
Amgen has showcased some encouraging early stage data from candidates based on its novel bispecific T cell engager (BiTE) platform at ASCO. Bispecific antibodies are one of the most promising emerging areas in immuno-oncology, with numerous biotechs and pharma companies developing their own variants of the technology. The potential is for the treatments to show
It was once a central tenet of biology that RNA molecules did their work inside the cell. But it’s now clear that RNA molecules are also active outside the cell, with potentially major implications for our health. To learn more about these unrecognized roles, the NIH Common Fund has launched the Extracellular RNA (exRNA) Communication Program. This month,
A new study led by scientists in the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) sheds light on one way tumors may continue to grow despite the presence of cancer-killing immune cells. The findings, published March 29, 2019, in Science, suggest a way to enhance the effectiveness of immunotherapies for 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
