AZ wins tightly-limited FDA OK for new thyroid cancer drug

AstraZeneca ($AZN) may have missed the blockbuster opportunity of treating lung cancer with vandetanib, but it picked up a significant consolation prize yesterday when the FDA approved the treatment for advanced cases of a rare form of thyroid cancer.

The FDA had delayed its decision on vandetanib for several months as it reviewed the company's proposal to limit the risks patients will be exposed to. A long list of side effects from the drug includes diarrhea, hypertension and headaches. But regulators were won over by the data, which demonstrated a significant increase in the survival rate for patients taking a once-daily dose.

In studies patients with metastatic medullary thyroid cancer gained an average of six months of progression-free survival, a significant factor for a group of patients with no alternatives once radiation and surgery fail to halt the cancer. "In an oncology practice, this is a meaningful benefit," oncologist Jack Jacoub told the Los Angeles Times.

Nevertheless, regulators are still alarmed by the risk of irregular heart beats; therefore, only physicians and pharmacies certified by the agency through its REMs program can provide the drug. That restriction could limit sales. Roughly three to five percent of all new thyroid cancer patients suffer from the medullary variety of the disease. Bloomberg notes the drug is expected to bring in about $82 million a year by 2015.

AstraZeneca had hoped to gain approval to use vandetanib to treat non-small cell lung cancer, a blockbuster indication. But those hopes were dashed after the therapy failed in clinical trials.

- here's the FDA's press release
- get the story from the Los Angeles Times
- check out the piece from Bloomberg