FDA to Hear Avistan’s Appeal Regarding Proposed Revocation of Drug Approval

Jul 11, 2011   

On June 28 – 29, 2011, Genentech appeared before the U.S. Food and Drug Administration (FDA) asking the Agency to reconsider its proposal to revoke Avastins approval for use in the treatment of breast cancer patients. The FDA approved Avastin three years ago through an accelerated approval process because Avastin is used to treat serious diseases and fills an unmet medical need. This accelerated approval process provides patients access to promising new drugs for treatment of serious or life-threatening conditions while awaiting the results of phase IV confirmatory clinical trials. If subsequent clinical trials fail to confirm the drugs clinical benefit, the FDA may take action to remove the drug from the market, see 21 C.F.R. § 314, subpart H. This marked the first time the FDA has held a hearing to consider a companys appeal of such a decision.

In February 2008, the FDA granted accelerated approval of Avastin for treatment of patients with breast cancer. The results of the initial clinical trial showed that patients treated with both Avastin and paclitaxel (chemotherapy) had a five and a half-month delay in the growth of their tumors when compared to patients who received paclitaxel alone. In spite of the fact that the clinical trial failed to provide evidence of prolonged life expectancy, the FDA granted drug approval.

Since then, the makers of the drug have conducted at least four clinical trials using Avastin in conjunction with other chemotherapy drugs. The results of these trials showed a much smaller delay in tumor progression, ranging from less than one month to approximately three months, and virtually no improvement in survival. In addition to the minimal improvement in a patients prognosis, Avastins side effects include bowel perforation, hemorrhaging, and organ damage or failure. Concerned that the drugs risks outweighed its benefits, the FDA convened the Oncologic Drugs Advisory Committee last year to vote on whether Avastins drug approval should be revoked. By a vote of 12 to 1, the panel moved to revoke Avastin’s approval for use in breast cancer treatment.

The FDAs decision has been a controversial one. Avistan is the worlds best-selling cancer drug, with revenues as high as $7 billion a year. Without FDA approval for use in treatment of breast cancer, Genentech could lose as much as $1 billion in annual sales. Even if Avastin loses its FDA approval here, the drug will continue to remain on the market because it is approved for treatment of other types of cancer and physicians can continue to prescribe Avastin off-label for breast cancer patients.

Many who oppose the FDAs decision are not placated by this alternative because insurance companies are unlikely to cover the costs of off-label prescriptions. For breast cancer patients who wish to continue using Avastin, these out-of-pocket costs could reach as high as $90,000 per year. Some even claim that the FDAs action may be the beginning of a slippery slope toward rationing of medication. FDA-supporters, however, are lobbying their concerns for public safety. Patient advocates assert that the FDA has a responsibility to remove Avistan from the market because cancer patients should only receive drugs that are proven effective for treatment.

Upon completion of the two-day hearing on June 29, 2011, the Oncologic Drugs Advisory Committee unanimously voted to revoke Avastins FDA approval for breast cancer treatment. The advisory committee also rejected Genentechs proposed compromise to keep the drug on the market while the company completes another phase IV clinical trial, which could take several years to complete. Genentech argued that despite the decrease in the delay of tumor growth exhibited in the clinical trials, Avastin still positively benefits breast cancer patients. After reviewing the data derived from these trials, however, the advisory committee was unconvinced that the drug significantly prolonged womens lives or improved the quality of their lives. Even though the committees decision is not final, the unanimous vote makes it seem more likely that FDA Commissioner Margaret Hamburg will move to rescind Avistans FDA approval. A final decision will not be made until after July 28, 2011, the close of the public comment period.

Fuerst Ittleman will continue to monitor developments in the FDAs regulation of drugs. For more information, contact us at contact@fidjlaw.com.