FDA Grants NKTR-102 Orphan Drug Status for Treatment of Ovarian Cancer

On April 21, Nektar Therapeutics announced that its oncology drug candidate, NKTR-102, has been granted orphan drug status by the FDA for the treatment with ovarian cancer.

Although many rare diseases, such as platinum-resistant ovarian cancer, affect small segments of the population (fewer than 200,000 people nationwide), drug companies are encouraged to develop products to treat these rare cancers, and if granted orphan drug status, these drugs in turn receive US market exclusivity for a particular indication for a 7-year period.

NKTR-102 is a next-generation topoisomerase I inhibitor with reduced peak concentrations and a continuous concentration profile. The drug is the first oncology-specific product using the advanced polymer conjugate technology platform developed by Nektar. The FDA announcement comes during an ongoing promising phase II trial that investigates the drug’s effectiveness in women with platinum-resistant ovarian cancer.

“This designation is an important step in the overall development program for NKTR-102 and underscores our commitment to treating women with ovarian cancer,” said Lorianne Masuoka, MD, Nektar’s Chief Medical Officer and Senior Vice President.

In addition to the phase II results for platinum-resistant ovarian cancer, NKTR-102 has also shown promise in a second phase II study in women with metastatic breast cancer. NKTR-102 is also currently being tested in a phase I clinical trial in combination with 5-fluorouracil therapy, as well as in a phase II study for its use as a single agent in patients with second-line colorectal cancer.