By Mary Welch
More than a year after a new drug application (NDA) for DepoCyt was filed and seven years since the drug entered Phase I/II trials, the FDA told DepoTech Corp. and partner Chiron Corp. that it is willing to consider an NDA for the product as a treatment for neoplastic meningitis from lymphomas — not from solid tumors, as the original submission asked.
"We're putting [the NDA] together now," said John Longnecker, president and CEO of San Diego-based DepoTech, adding the FDA has already seen the pertinent information, which was contained in the first filing as support data.
The agency said it would support an application for accelerated approval and would review that application expeditiously, and then decide whether it will be reviewed by the Oncologic Drugs Advisory Committee.
DepoCyt is an injectable, sustained-release formulation of the chemotherapeutic agent cytarabine. It is delivered by DepoTech's lipid-based encapsulation system, DepoFoam, and injected every two weeks directly into the cerebrospinal fluid as a treatment for neoplastic meningitis. DepoTech is developing the drug with Chiron, of Emeryville, Calif.
In May, DepoTech received a not-approvable letter from the FDA, saying DepoCyt clinical trials failed to decisively prove the drug offers relief from neoplastic meningitis.
The company had presented an FDA advisory panel with the pivotal clinical trial results in December 1997. That trial involved 61 patients, 31 of whom received DepoCyt once every two weeks and 30 who received methotrexate injections twice a week.
Eight of the patients on DepoCyt had a complete response and six in the methotrexate arm experienced a complete response. This result failed to reach statistical significance.
However, patients on DepoCyt experienced a median time to progression of their disease of 166.5 days, while those on methotrexate saw their symptoms become worse in a median of 66.5 days.
The panel said time to clinical progression was insufficient to recommend approval. It decided the study was neither adequate nor well-controlled and refused to make a recommendation on approval. (See BioWorld Today, Dec. 19, 1997, p. 1.)
DepoTech laid off 29 employees in February, and restructured the company.
In April, the company included — as part of an amendment to the NDA for the solid tumor indication — data from 28 patients in a controlled trial of DepoCyt for neoplastic meningitis from lymphoma.
DepoTech's stock (NASDAQ:DEPO) closed Wednesday at $1.937, up $0.062. Chiron's shares (NASDAQ:CHIR) ended the day at $14.312, down $0.687. *