FDA approves Bayer’s Stivarga
pharmafile | October 1, 2012 | News story | Research and Development, Sales and Marketing | Bayer, FDA, KRAS, Roche, Stivarga, avastin
The FDA has approved Bayer HealthCare’s oncology pill Stivarga to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after previous treatments.
The US regulator gave Stivarga (regorafenib) priority review after it was shown to extend overall survival (OS) in this patient group in a pivotal Phase III trial.
The drug is co-marketed with Onyx, and the firms expect to make more than €2 billion ($2.8 billion) in peak annual sales from their oral multi-kinase inhibitor.
Colorectal cancer is the fourth most common cancer worldwide, with over one million cases every year and an average five-year survival estimate of 55 per cent.
Stivarga has demonstrated that it increases OS for late-stage patients compared to placebo.
This is a competitive therapy area, with other approved treatments for mCRC including Merck KGaA’s Erbitux (cetuximab) and Amgen’s Vectibix (panitumumab).
Others are also challenging: in August the FDA approved Sanofi and Regeneron’s Zaltrap (ziv-aflibercept), in combination with chemotherapy, for mCRC patients whose tumours have progressed after an oxaliplatin-containing chemotherapy regimen.
The FDA said Stivarga can be used in mCRC patients whose previous therapies include fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy or an anti-VEGF therapy.
If it is a KRAS wild type, those treatments can also contain an anti-EGFR therapy – around 40% of colorectal cancers have mutations in the KRAS gene.
FDA approval was based on results from the CORRECT trial, which showed median OS of 6.4 months with Stivarga versus 5.0 months with placebo.
Median progression-free survival (PFS) was 2.0 months with Stivarga and 1.7 months with placebo and there was a survival benefit (OS and PFS) in the Stivarga arm across nearly all subgroups analysed.
The FDA’s green light “marks the first approval of this innovative cancer treatment to fulfill a significant unmet medical need in the treatment of mCRC”, said Bayer chief executive Jörg Reinhardt.
Adam Hill
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