Lilly’s lung cancer drug in combo with gemcitabine and cisplatin gets FDA’s OK

Eli Lilly has gotten the U.S. Food and Drug Administration (FDA) approval for cancer drug Portrazza, which comes in a form of injection for intravenous use, 800 mg/50 mL, in combination with gemcitabine and cisplatin.

As Lilly said on Tuesday, this is the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for treatment of nonsquamous NSCLC, Lilly noted.

Advances in lung cancer in last two decades

“We have seen advances in lung cancer in the last 20 years, but not for the initial treatment of patients battling metastatic squamous non-small cell lung cancer. This is a complex disease and there is an urgent need for effective, first-line treatments,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology.

“The approval of Portrazza is an important step forward that reaffirms Lilly’s commitment to discovering new treatments that respond to the needs of individual patients,” Gaynor added.

Furthermore, Portrazza has been granted Orphan Drug Designation by the FDA. Orphan drug status is given in the U.S. by the FDA’s Office of Orphan Products Development (OOPD) to medicines that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

“Lung cancer is an extremely complicated disease that requires a variety of therapy options so doctors can choose an appropriate treatment for each patient’s unique circumstances,” said Bonnie J. Addario, founder and chair of the Bonnie J. Addario Lung Cancer Foundation, and a lung cancer survivor.

“Today’s approval represents progress for patients diagnosed with metastatic squamous non-small cell lung cancer, as each new therapy advances cancer care and gives patients hope for improved outcomes.”