The FDA has granted duvelisib (Copiktra) with an orphan drug designation for the treatment of patients with T-cell lymphoma, according to a press release from Verastem Oncology, the company developing duvelisib.1 The PI3K-δ,γ inhibitor demonstrated efficacy in a phase I study and is currently being investigated in the phase II PRIMO trial (NCT03372057). “Receiving orphan
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Glenmark Pharmaceuticals’ bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies. “Patients who are struggling with diseases like
Novartis has reported positive findings from the Phase III ASCLEPIOS I and II clinical trials of ofatumumab (OMB157), which met their primary endpoints in relapsing forms of multiple sclerosis (RMS) patients. Ofatumumab is an anti-CD20 monoclonal antibody (mAb) designed to cause B-cell lysis and depletion. It has been formulated for once-monthly, subcutaneous self-administration. The identical
Immunotherapy can be effective in treating certain types of pediatric blood cancers, but researchers are still exploring how this type of treatment could work for pediatric solid tumors. In clinical trials, scientists are combining immunotherapy agents in an effort to jump-start the immune system against pediatric solid tumors. Source DANA-FARBER Cancer Institute New treatments that
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
