Drug Criteria & Outcomes

New FDA Approvals

FDA recently approved these drugs:
• QLT USA's metronidiazole vaginal gel, 0.75%, the first generic version of 3M's MetroGel-Vaginal was approved for treating bacterial vaginosis. FDA said QLT callenged certain patents for the branded drug and is eligible for 180 days of marketing exclusivity. The agency also said the approval is an important step in its efforts to increase availability of lower-cost generic drugs.

• Genentech's trastuzumab (Herceptin®) was approved for an expanded indication of treating HER2-positive breast cancer after surgery in combination with other cancer drugs. FDA gave priority review to the supplemental application for the new indication. Herceptin was first approved in 1998 for treating metastatic breast cancer. The new approval expands its use to women with cancer only in the breast or lymph nodes that has been removed with surgery. FDA said trastuzumab should only be prescribed for women diagnosed with HER2-positive breast cancer.

Trastuzumab is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective.

The two studies leading to the new approval were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trials group. Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given trastuzumab. Due to positive trial results, the National Cancer Institute ended the studies early. The results showed that women who received trastuzumab combined with chemotherapy had fewer relapses for up to three years after surgery. The estimated three-year disease-free rates were 87% in women receiving trastuzumab and chemotherapy and 75% for those receiving chemotherapy alone. FDA said it is too soon to know whether trastuzumab combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.

• The first generic versions of GlaxoSmithKline's Zofran (ondanestron) injection and Zofran injection premixed were approved. Ondanestron is indicated for preventing nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy and preventing postoperative nausea and vomiting.

Ondanetron injection packaged in single and multidose vials is manufactured by Teva Pharmaceuticals, while the premixed injection is manufactured by SICOR Pharmaceuticals. FDA said GlaxoSmithKline agreed to waive the remainder of a six-month exclusivity period to permit approval of the Teva and SICOR applications. According to trade publications, Zofran was the 20th most expensive brand name drug used in hospitals in the United States and approval of the generic equivalents will lead to significant cost savings.