GSK’s Oncology Expansion Heavily Dependent On Dabrafenib, Trametinib
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline announced NDA filings for BRAF inhibitor dabrafenib and MEK inhibitor trametinib in metastatic melanoma on Aug. 3. The two compounds represent one-quarter of the company’s novel oncology agents in clinical development, according to the most recent pipeline update.
You may also be interested in...
GlaxoSmithKline Pulls Tykerb sNDA Ahead Of FDA Panel Review
The sponsor withdrew the application for combination use of lapatinib with Roche’s Herceptin in breast cancer less than two weeks before a scheduled advisory committee review, because of questions from FDA “that could not be addressed with the data currently available.” Those questions may have been driven by concerns about the clinical meaningfulness of a four-week median progression-free survival benefit and other efficacy issues.
GlaxoSmithKline Deals One-Two Punch With BRAF/MEK Pair
GSK presented Phase III results for its BRAF inhibitor dabrafenib and its MEK inhibitor trametinib at the American Society of Clinical Oncology annual meeting June 4. But the real excitement is over the just-starting Phase III trial combining the two drugs.
FDA Opts For Full, Rather Than Accelerated, Approval Of GSK’s Votrient In Sarcoma
Despite advisory committee discussion about a possible accelerated approval for pazopanib with a confirmatory study to assess symptom benefit, the agency opted to grant regular approval, as had been requested by GlaxoSmithKline.