Bayer seeks FDA approval for Stivarga to treat advanced liver cancer

The company submitted a supplemental new drug application (sNDA) to teh FDA for Stivarga tablets for the second-line systemic treatment of patients with unresectable hepatocellular carcinoma (uHCC).

The drug was previously approved by the FDA to treat metastatic colorectal cancer (mCRC) and metastatic gastrointestinal stromal tumor (GIST).

Bayer senior vice president and Americas medical affairs head Dario Mirski said: “For nearly a decade and counting, Bayer has been committed to meeting the needs of those with liver cancer with our proven first-line systemic therapy in unresectable HCC patient's therapy, Nexavar.”

"Clearly, more options are needed for these patients, especially in the second-line setting. The filing of Stivarga in HCC demonstrates our commitment to ongoing research in this difficult-to-treat cancer."

Stivarga’s sNDA was submitted based on a successful placebo-controlled Phase III trial dubbed RESORCE.

The trial statistically showed significant improvement in overall survival in unresectable Hepatocellular carcinoma (HCC) patients subjected to Stivarga.

According to Bayer, 573 patients whose disease had progressed during treatment with sorafenib, had enrolled in the trial. Randomized in a 2:1 ratio, the patients were subjected to either regorafenib or placebo plus best supportive care (BSC).

While the primary endpoint was overall survival, the secondary endpoints were time to progression, progression-free survival, objective tumor response rate besides disease control rate. Bayer has said that regorafenib has returned favorable data for the primary and secondary endpoints leading it to file a sNDA.

Stivarga has already been granted a Fast Track designation from the FDA as it has been developed to be used in the treatment of life-threatening cancers.