The FDA approved Pharmacyclics' (PCYC) ibrutinib to treat patients with mantle cell lymphoma, the agency just announced.
Ibrutinib will be sold under the brand name Imbruvica and is available immediately at a jaw-dropping price of $91.90 per pill, or $130,000 per year, for mantle cell lymphoma, making it among the highest-priced cancer drugs marketed in the U.S. Celgene's (CELG) multiple myeloma drug Revlimid, at $150,000 per year, is priced higher.
Investors were expecting Pharmacyclics to price Imbruvica at about $110,000 per year, so Wall Street is likely to be pleased with the company's aggressive price strategy. Insurance companies who will shoulder most of the drug's cost may not be as sanguine. Pharmacyclics is setting up a program to offer two months of free drug to patients who encounter reimbursement problems and co-payment assistance plans for patients who cannot afford the drug.
Pharmacyclics shares rose 3% to $122.87 following the approval announcement.
Pharmacyclics submitted Imbruvica for approval to treat chronic lymphocytic leukemia as well but that review is still underway at FDA, the company said.
Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma and represents about 6 percent of all non-Hodgkin lymphoma cases in the United States. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow and other organs. Imbruvica was approved as a treatment for MCL patients who have received at least one prior therapy.
There are approximately 11,000 MCL patients in the U.S., with 3,000 patients diagnosed each year, Pharmacyclics said.
Imbruvica's accelerated approval for MCL is based on a study where 111 participants were given Imbruvica daily until their disease progressed or side effects became intolerable. Results showed nearly 66 percent of participants had their cancer shrink or disappear after treatment (overall response rate). An improvement in survival or disease-related symptoms has not been established, the FDA said.
Johnson & Johnson (JNJ) is Pharmacyclics' co-marketing partner.