Pfizer Inc. won U.S. approval to sell a drug targeted at a form of lung cancer caused by a gene defect, as the world’s largest drugmaker seeks tumor-fighting medicines to replace sales expected to be lost to generics.
The treatment, crizotinib, was cleared five weeks ahead of schedule for patients with late-stage, non-small cell lung cancer with a rare genetic abnormality, the Food and Drug Administration said yesterday in a statement. Pfizer will sell the twice-a-day pill under the name Xalkori. The agency also approved a companion test made by a unit of Abbott Laboratories to determine whether a patient has the abnormal ALK gene.
The drug is among more than 20 cancer medicines that may help New York-based Pfizer offset $11 billion in revenue at risk to generic copies of the best-selling Lipitor cholesterol pill. In a study presented at a conference last year, the drug reduced tumor size in 57 percent of patients and stopped progression of the disease in 87 percent.
“Xalkori represents a new chapter in personalized therapy for lung cancer, enabling physicians to provide the right treatment for the right patient,” said Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s oncology business unit.
The treatment may generate sales of $540 million by the end of 2015, according to the average estimate of four analysts surveyed by Bloomberg.
The drug, the first new lung-cancer treatment approved by the FDA in more than six years, is available immediately through specialty pharmacies, Pfizer said in a statement. Xalkori also is the first lung-cancer treatment developed and approved with a diagnostic test, the company said.
“Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
About 221,000 cases of lung cancer will be diagnosed in the U.S. this year and the disease will kill about 157,000 people, according to the National Cancer Institute.
The ALK gene abnormality causes cancer development and growth and affects about 1 percent to 7 percent of those with the non-small lung cancer, the most common form of the disease, the FDA said in its statement.
“The Abbott-Pfizer collaboration marks a breakthrough in the advancement of personalized medicine -- and companion diagnostics specifically -- that will help a subset of lung-cancer patients get treatment tailored to their unique genetic profile,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business, in a company statement.
Pfizer’s drug is the second cancer therapy approved by the FDA this month in conjunction with a diagnostic test. Zelboraf, a skin-cancer drug from Roche Holding AG and Daiichi Sankyo Co., won FDA clearance Aug. 17 with a Roche companion test that helps detect whether patients have the gene mutation the drug targets.
Xalkori is the third cancer drug this month to win FDA clearance ahead of schedule. The FDA had a Sept. 30 target decision date for Pfizer’s new treatment, and an Oct. 28 date for Zelboraf. The agency approved Seattle Genetics Inc.’s lymphoma drug Adcetris on Aug. 19, 11 days early.
All three drugs were evaluated under six-month priority reviews. While the FDA typically takes at least 10 months to rule on drug applications, it grants priority status to therapies that may provide major advances in treatment.
Lipitor, the world’s best-selling drug, will face generic competition in the U.S. starting Nov. 30 if Ranbaxy Laboratories Ltd. wins FDA approval to begin selling a copy of the medicine by then.
Watson Pharmaceuticals Inc. has an agreement with Pfizer to start selling a so-called authorized generic on Nov. 30. Pfizer will provide Lipitor to Watson to sell without the brand label as a generic in return for a share of the sales.