This story originally ran on The Hill.
This week, Pfizer asked the U.S. Food and Drug Administration to allow 16- and 17-year-olds to have the same access to AstraZeneca’s breakthrough cancer drug Imfinzi as 18- and 19-year-olds.
The health care titan wants to apply an experimental “evaluation pathway” for the drug, which it developed in partnership with the pharma giant that puts two powerful drugs in one pill. The American Cancer Society describes the drug as “one of the best new treatments for lung cancer available today.”
The decision was announced by Chairman and CEO Ian Read.
In a press release, the company said the decision was based on an analysis by data science and drug development expert Michael Klausner, of the Perelman School of Medicine at the University of Pennsylvania, suggesting “new data-driven approaches are needed to develop more therapies for life-threatening lung cancer.”
The inclusion of a child may change the distribution of prescriptions, which could affect what happens to the price of the drug, since AstraZeneca began selling Imfinzi under a prescription-only program for the first time in the U.S. in early 2018.
Imfinzi drugs cost about $10,000 per month at a discount, but a full course of three-month shots costs patients and their families $65,000, said Tyler Willard, medical director of lung cancer at Philadelphia’s Winship Cancer Institute, as reported by the New York Times in August.
Pfizer currently applies a three-stage approval process for AstraZeneca’s Imfinzi. The company had sought expedited approval that could have been applied to children at “high risk of potentially life-threatening complications,” according to an FDA timeline set forth in August.
Despite support from asthma, allergy and other experts, the FDA’s Division of Oncology Drug Products cautioned against the decision, arguing that the potential for an increased rate of allergic reactions and allergic conjunctivitis might outweigh the benefit to patients, as reported by the New York Times in September.
A few months later, Pfizer decided to get rid of that particular risk, opting to go with a single pathway for adults.