Trending News Today: Spectrum Submits sBLA for Eflapegrastim for Treatment of Neutropenia
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Spectrum Pharmaceuticals has submitted a supplemental Biologics License Application (sBLA) to the FDA for eflapegrastim for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs, the company reported in a press release. According to Spectrum, the sBLA is supported by data from the ADVANCE and RECOVER phase 3 trials, which included 643 early-stage patients with breast cancer. The results demonstrated eflapegrastim’s non-inferiority in Duration of Severe Neutropenia and a similar safety profile of pegfilgastrim, the press release said.
Results from a phase 1 study showed that an experimental drug from Mirati Therapeutics significantly reduced tumor size in some patients with lung and colorectal cancers, Reuters reported. According to the article, the study, which enrolled 17 patients, evaluated the oral treatment MRTX849. Overall, 3 of the evaluated patients with lung cancer had a “partial response,” defined as a 30% or more reduction in tumor size and 1 of the evaluated patients with colorectal cancer also had a partial response, the article reported.
A 3-year study shows promise for an experimental vaccine being developed by GlaxoSmithKline for the prevention of active tuberculosis (TB), The Associated Press reported. According to the article, the vaccine was tested in approximately 3600 adults in Africa who were infected with TB, but who did not also have HIV. Overall, the vaccine proved 50% effective, with 13 individuals in the vaccine group and 26 in the other group developing active TB, the article reported.