RESEARCH TRIANGLE PARK, NC--Navelbine (vinorelbine tartrate), a semisynthetic vinca alkaloid, has become the first new treatment to receive FDA approval for inoperable advanced non-small-cell lung cancer (NSCLC) in 20 years, Burroughs Wellcome Co., manufacturer of Navelbine, announced at a telephone news conference.
Single Agent or Combination
Specifically, the drug is licensed for use in ambulatory stage III and IV patients, to be used as either a single agent or in combination with cisplatin(Drug information on cisplatin) (Platinol) in stage IV patients, and only in combination in stage III patients.
"Although it is not a cure, Navelbine is an important advance in treatment options, potentially prolonging life, with more manageable side effects than other commonly used chemotherapy agents," said Richard Tuttle, PhD, director of cancer therapy at Burroughs Wellcome.
The agent was developed by Pierre Fabre Medicament in France, where it is marketed for NSCLC and advanced breast cancer, and has been developed for use in North America by Burroughs Wellcome under a licensing agreement with Pierre Fabre, Dr. Tuttle said.
Richard Gralla, MD, director of the Ochsner Cancer Institute, said that the agent is well tolerated on an outpatient basis, "allowing patients to pursue their normal activities." He noted that Navelbine generally does not cause nausea, and if it does occur, it is easy to treat or prevent. Alopecia and peripheral neuropathy are also uncommon.
In two major controlled trials involving more than 800 advanced NSCLC patients, Navelbine increased survival when used as a single agent or in combination with cisplatin. In a large European trial, those receiving the combination had a median survival of 40 weeks, compared with 31 weeks for patients treated with Navelbine alone, and 32 weeks for those treated with cisplatin and vindesine(Drug information on vindesine), a common regimen in Europe.