Genentech amends approval application for expanded use of Avastin
SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.
Genentech, part of Swiss drug maker Roche, is seeking approval for Avastin (bevacizumab) combined with paclitaxel chemotherapy for untreated advanced breast cancer without the HER2 protein. The FDA has granted accelerated approval to Genentech’s application, and the company expects the agency to take action by Dec. 17. The expected action date is based on the FDA’s decision to extend its review period in light of the amendment.
“We are pleased by the FDA’s decision to review additional information on Avastin and are committed to working with the agency during this extended review period,” Genentech EVP product development and chief medical officer Hal Barron said.
Avastin already is approved for treating cancers of the colon and rectum, lungs and kidneys.
BI commences late-stage clinical trial for breast cancer treatment
INGELHEIM, Germany Boehringer Ingelheim has started a late-stage clinical trial of a drug for treating breast cancer, the German drug maker said Friday.
The phase 3 trial, dubbed the “LUX-Breast 1” trial, will evaluate the drug afatinib in patients with advanced breast cancer. The drug is a tablet that BI said was the first to inhibit two chemicals involved in tumor growth — the epidermal growth factor receptor, or EGFR, and the human epidermal receptor, also known as HER2.
“We have seen positive results in our proof-of-concept studies for afatinib in breast cancer, and are glad to advance the program into pivotal phase 3,” BI corporate SVP medicine Klaus Dugi said. “We are delighted to be able to initiate this important trial together with a range of leading investigators to assess the value of afatinib for women with advanced breast cancer.”
Emergent to develop anthrax vaccine on HHS’ behalf
WASHINGTON Emergent BioSolutions has landed a $51 million contract from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to develop a new anthrax vaccine.
In the first two years of the contract, Emergent will develop the final vaccine formulation and test its stability. HHS said it can extend the contract annually for up to three years to support scale-up and optimization for large-scale manufacturing, as well as additional animal studies needed to apply for Food and Drug Administration approval of the vaccine.
If the government extends the contract for all three years, the total five-year contract value could be $186.6 million.