FDA approves Lilly’s Gemzar in ovarian cancer

Gemzar, which is already approved in lung, pancreatic and breast cancer, generated sales of $1.3 billion last year, making it Lilly’s second best-selling drug.

In the latest approval, the FDA specified that Gemzar can be used in combination with carboplatin, a widely-used agent, for women with advanced ovarian cancer that has relapsed at least six months after initial therapy.

Clinical data submitted to the FDA showed that patients treated with a combination of Gemzar and carboplatin experienced a significant improvement in progression-free survival and response rates compared to carboplatin alone.

Results showed a median progression-free survival increase of 48% in the Gemzar and carboplatin arm compared to the carboplatin arm (8.6 months vs. 5.8 months). The Gemzar combination also demonstrated a two-fold increase in complete response rate, defined as disappearance of tumor, over carboplatin alone (14.6 percent vs. 6.2 percent, respectively).

“The Gemzar and carboplatin combination offers one of the most active treatment regimens available for a platinum-sensitive disease with less risk of having neurotoxicity and significant alopecia, making this a valuable treatment option for the treatment of recurrent platinum-sensitive ovarian cancer,” said Dr Tate Thigpen, professor of medicine and director of oncology at the University of Mississippi School of Medicine.