The Food and Drug Administration ended April granting new indications to oncology drugs owned by two prominent pharmaceutical companies.
First up is Bayer’s Stivarga (regorafenib). The drug gained a label expansion to treat hepatocellular carcinoma (HCC), which is the most common form of liver cancer. Stivarga is a kinase inhibitor that works by blocking several enzymes that foster cancer growth, according to the FDA’s announcement.
The agency made its decision based on data from a clinical trial of 573 patients diagnosed with HCC.
Investigators wanted to assess the drug’s efficacy based on metrics like overall survival, progression-free survival, and overall response rate.
Results showed that the medial overall survival for these patients taking Bayer’s therapy was 10.6 months compared to 7.8 months for patients taking the placebo while median progression-free survival for Stivarga patients was 3.1 months versus 1.5 months for placebo. Overall response rates reached 11 percent compared to 4 percent on placebo.
Stivarga’s other indications include colorectal cancer and gastrointestinal stromal tumors for people who are no longer responding to previous treatments.
An approximate 40,710 people will be diagnosed with liver cancers this year whereas about 28,920 will die from this condition, according to statistics from the National Cancer Institute.
Next, Novartis gained a positive nod from the agency for Rydapt (midostaurin), which is another kinase inhibitor engineered to block a number of enzymes that promote cell growth.
The drug is intended as a treatment used in conjunction with chemotherapy for newly diagnosed adult patients with acute myeloid leukemia who also have a certain genetic mutation called FLT3. A companion diagnostic needs to be used to detect the alteration.
Data from a randomized trial of 717 patients who had not been treated previously for AML supported the FDA’s decision.
Results from the investigation indicated patients who took Rydapt in combination with chemotherapy lived longer than their counterparts who took chemotherapy alone, per the FDA’s statement.
Specific median survival rates could not be reliably estimated, but patients taking the Rydapt-chemotherapy combination went longer without certain complications like failure to achieve complete remission within 60 days of starting treatment compared to patients on chemotherapy. The median for the former was 8.2 months while the latter hit a median of three months.
Also, the FDA gave approval for certain types of rare blood disorders like aggressive systemic mastocytosis and systemic mastocytosis.
The drug will be available on Monday May 1st, reported Reuters.
The National Cancer Institute estimates that an approximate 19,930 people would be diagnosed with AML in 2016 with about 10,430 projected to succumb to the disease.