Bayer submits US regorafenib application in GIST
This article was originally published in Scrip
Bayer HealthCare submitted its new drug application (NDA) to the US FDA for regorafenib as a treatment for patients with metastatic or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment, the firm and its partner, Onyx Pharmaceuticals, said on 30 August.
Last year, Bayer entered into an agreement with Onyx, which stands to gain royalties on any future global net sales of regorafenib in oncology.
Once approved, Bayer and Onyx will jointly promote regorafenib in the US for GIST.
In May, Bayer submitted an application for regorafenib as a treatment for patients with metastatic colorectal cancer (scripintelligence, 24 May 2012).
Bayer's submission of regorafenib in GIST was based on data from a randomized, double-blind, placebo-controlled, multi-center, cross-over pivotal Phase III study, known as GRID, which showed the drug plus best supportive care (BSC) significantly improved progression-free survival (PFS), versus placebo plus BSC in patients with metastatic or unresectable GIST previously treated with Novartis' Gleevec (imatinib) and Pfizer's Sutent (sunitinib).
The median PFS was 4.8 months in the regorafenib arm, versus 0.9 months in the placebo arm, and there was a positive trend in the regorafenib group in improving overall survival. The study design allowed patients receiving placebo to cross-over to regorafenib following disease progression.
The most frequently reported drug-related adverse events greater than or equal to 25% in regorafenib-treated patients versus placebo-treated patients, respectively, were hand-foot skin reaction, hypertension, diarrhea, fatigue and oral mucositis.
Bayer noted that the FDA recently agreed to permit the firm to proceed with its expanded access program (EAP) to provide regorafenib to patients diagnosed with GIST through qualified clinical sites participating in the EAP.