By Randall Osborne

In an agreement with the FDA regarding the company's stalled anticancer drug, DepoTech Corp. will submit more trial data and wait up to three months longer for a finished review of its new drug application (NDA).

"It's one of the better outcomes, if you look at the various scenarios that could have occurred," said Dana McGowan, CFO for San Diego-based DepoTech.

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted against the company's DepoCyt late last year, saying the single Phase III trial was too small to support the NDA and had no evaluable endpoint. Last month, DepoTech restructured, suspending development of two products and laying off 29 people. (See BioWorld Today, Dec. 19, 1997, p. 1 and Feb. 4, 1998, p. 1.)

DepoCyt is a sustained released formulation of the chemotherapeutic agent cytarabine, which the company is developing for patients with neoplastic meningitis from solid tumors, lymphomas and leukemia. Chiron Corp., of Emeryville, Calif., is DepoTech's U.S. marketing partner for the drug.

"[The FDA] could have given us a 'no' vote, or had us finish all the trials and then submit," McGowan told BioWorld Today.

In the amended NDA, data from a Phase IV clinical trial will be submitted, along with interim data from a Phase III study of neoplastic meningitis patients with lymphoma and leukemia.

"We're over-enrolled in the Phase IV trial," McGowan said. "Rather than wait until it's complete, the FDA said we only have to submit what we already have in-house, but that data would double the study size."

The Phase IV trial is customary to back up safety and efficacy data used in the NDA, but usually is filed as a supplement.

"We happened to get lucky to have the data on hand," McGowan said, because the Phase IV study was begun early.

The FDA extends the review period's deadline by three months, to July 28, 1998.

"They have to give us a 'yes' or 'no' by then," she said. "Another question is whether we have to go back to ODAC again. We don't have any indication at this point."

DepoTech's stock (NASDAQ:DEPO) closed Monday at $6.25, up $0.25. *

No Comments