Ligand Pharmaceuticals Inc.'s Targretin cancer drug was approved on Wednesday by the Food and Drug Administration, giving patients with a rare form of lymphoma a new treatment.
The approval clears the San Diego-based company to market Targretin for use in treating advanced cutaneous T-cell lymphoma, making it the company's third treatment for rare cancers. The approval follows a recommendation made two weeks ago by an FDA panel.
Ligand is counting on Targretin to help the company meet its goal of turning its first quarterly profit next year, said James McCamant, a fund manager and the editor of Medical Technology Stock Letter.
"It will probably be their largest-selling product," said McCamant, who said the drug could generate as much as $100 million in annual sales to lymphoma patients. If continuing clinical trials show the drug is effective against breast cancer, McCamant said, sales could eventually top $300 million a year.
Ligand shares rose $1.63, nearly 17%, to close at $12.75 on Nasdaq.
Patients with lymphoma can develop scales and patches on their skin that itch and become inflamed, making them vulnerable to infections. Such infections are often the immediate cause of death in patients, experts said.
Targretin received the backing of an FDA advisory panel earlier this month for patients with advanced forms of the disease.
The final approval from the agency grants the company a broader use of the drug than the panel had recommended; the company may market the drug for use in treating both patients who have early-stage and those with late-stage cutaneous T-cell lymphoma. The panel voted 5 to 7 against recommending that the drug be approved for patients in early stages of the disease.
"The approval of Targretin capsules for both early and late-stage refractory CTCL is a welcome sign of progress for suffering patients, as well as very positive for the company," Ligand Chief Executive David Robinson said.
Targretin, which is dispensed in capsules, will join a Ligand drug portfolio that includes Ontak, an intravenous treatment for cutaneous T-cell lymphoma, and Panretin, a topical gel for the AIDS-related skin cancer called Kaposi's sarcoma.