FDA Okays Gemzar-Paraplatin Duo for Recurrent Ovarian Cancer

INDIANAPOLIS, July 17 -- The FDA has approved Gemzar (gemcitabine) in combination with Paraplatin (carboplatin) for treatment of recurrent ovarian cancer, Eli Lilly announced today.

Clinical trial data submitted to the FDA showed that the Gemzar-Paraplatin combination was associated with a significant improvement in progression-free survival compared with Paraplatin monotherapy, 8.6 months versus 5.8 months (P=0.0038).

The randomized phase III study from the Gynecologic Cancer Intergroup compared Gemzar plus Paraplatin to Paraplatin alone in locally advanced or metastatic disease in patients previously treated with platinum-based therapy such as carboplatin or Platinol (cisplatin). The primary endpoint of the 356-patient trial was progression-free survival.

The combination demonstrated a twofold increase in the complete response rate compared with Paraplatin alone (14.6% versus 6.2%). The overall response rate for the Gemzar-Paraplatin combination was significantly higher than the overall response to Paraplatin -- 47% versus 31% (P=.0016).

The most commonly observed side effect of the combination therapy was neutropenia. Grade 3 and 4 toxicities were primarily hematological laboratory toxicities, such as anemia and thrombocytopenia, and hemorrhage.

There have been rare reports of serious kidney, lung or liver toxicity with Gemzar treatment. The company said Gemzar treatment will likely not be appropriate for women who are pregnant, may be pregnant or are nursing.