GlaxoSmithKline's FDA application accepted for Hycamtin, granted priority review

By Elaine Rigoli

Tampa, Fla., Feb. 17 - GlaxoSmithKline announced Friday that the FDA has accepted its supplemental New Drug Application for Hycamtin (topotecan HCl) for injection to treat advanced cervical cancer. The FDA has also agreed to a priority review.

The application seeks marketing approval for the new use of Hycamtin in combination with cisplatin, for the treatment of Stage 4B recurrent or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy, according to a company news release.

The application is based on results from a randomized, multicenter phase 3 trial, designed and conducted by the Gynecologic Oncology Group.

Hycamtin is currently indicated for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy, and for the treatment of small cell lung carcinoma sensitive disease after failure of first-line therapy.

Cervical cancer is the third most common gynecological cancer among American women, with close to 12,000 new cases diagnosed annually, the release stated.

"Prognosis is positive if the disease is discovered early; however, expectations drop dramatically for those patients with advanced stage disease," explained Kevin Lokay, vice president of oncology and acute care, in a company statement.

"We are committed to improving the options available for these patients, and we see our collaboration with the GOG [Gynecologic Oncology Group], in submitting their pivotal trial results, as very important to our commitment and achieving that goal."

The trial demonstrated a survival advantage with the use of Hycamtin in combination with cisplatin compared to cisplatin alone. The trial enrolled women with measurable, histologically proven stage 4B recurrent or persistent carcinoma of the cervix, who had recovered from the effects of prior surgery, radiation or chemoradiation.

Patients were originally randomized into three arms: single-agent cisplatin (50 mg/m2 q 3 weeks), cisplatin plus Hycamtin (Hycamtin 0.75 mg/m2 d1-3 plus cisplatin 50 mg/m2 d1 q 3 weeks), or MVAC (methotrexate, vinblastine, doxorubicin and cisplatin q 4 weeks).

However, the MVAC arm was closed after 64 patients were enrolled, due to excessive toxicity, the release stated.

The company statement also released the results from 146 patients who received cisplatin alone and 147 who received the combination of cisplatin plus Hycamtin.

The study showed an improvement in median overall survival of 9.4 and 6.5 months (P = 0.017), median progression-free survival of 4.6 and 2.9 months (P = 0.014). There was also an increased overall response rate, 13% for cisplatin alone and 27% for cisplatin plus Hycamtin, (P = 0.004).

GlaxoSmithKline is based in Philadelphia and is a research-based pharmaceutical and health care company.

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