(Reuters) - The U.S. Food and Drug Administration said it had approved Eli Lilly & Co’s Portrazza, in combination with two forms of chemotherapy, to treat patients with a type of lung cancer.
However, the treatment will need to carry a "boxed warning" that flags potential fatal risks, including cardiac arrest and sudden death. (1.usa.gov/1NbzJZ8)
A 1,093-patient clinical trial showed that patients who received Portrazza, along with chemotherapy drugs gemcitabine and cisplatin, survived an average of 11.5 months compared with 9.9 months for those who received only chemotherapy treatments.
The FDA’s approval on Tuesday comes about four months after an advisory panel to the agency recommended the drug be cleared for sale along with the warnings.
Lung cancer is the leading cause of cancer death in the United States, with about 221,000 new diagnoses and 158,000 deaths so far in 2015.
Portrazza is approved to treat advanced squamous non-small cell lung cancer, the most common type of lung cancer.
It is not approved for the second type of non-small cell lung cancer, non-squamous cell.
Eli Lilly’s shares were down 1.5 percent at $83.43 in early afternoon trading on the New York Stock Exchange.
Reporting by Ankur Banerjee and Rosmi Shaji in Bengaluru; Editing by Anil D'Silva and Ted Kerr