Citing safety concerns, Lilly suspends cancer drug trial
INDIANAPOLIS — Eli Lilly is suspending a late-stage clinical trial of a cancer drug amid safety concerns, the drug maker said Monday.
The company had been conducting a phase-3 trial of the pharmaceutical drug tasisulam as a second-line treatment for patients with melanoma whose cancer could not be removed or had spread to other parts of the body. Melanoma, the deadliest form of skin cancer, is diagnosed in 68,000 people in the Untied States every year, according to the American Cancer Society.
Trials of the drug in patients with leukemia, soft tissue sarcoma, breast, ovarian and kidney cancers will continue due to differences in dosing.
“We are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial,” said Richard Gaynor, Lilly VP oncology product development and medical affairs.
Regulatory approval application accepted for Exparel
PARSIPPANY, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.
The drug maker submitted its application for the long-acting painkiller Exparel (bupivacaine) in September.
The drug is a topical medication for managing pain following surgery. The FDA expects to finish reviewing the application in July 2011.
FDA approves revised dosage of HIV-combo drug
TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.
Tibotec Therapeutics, a J&J subsidiary, announced the FDA’s approval in adults of a once-daily combination of its Prezista (darunavir) and Abbott’s Norvir (ritonavir), which combines 800 mg of Prezista with 100 mg of Norvir. The previously approved dosage was 600 mg of Prezista and 100 mg of Norvir taken twice per day.
“With this once-daily dosing recommendation, boosted Prezista is now a viable option for more treatment-experienced patients,” Tibotec president Glenn Mattes said. “This approval reflects Tibotec’s ongoing commitment to optimizing dosing strategies for HIV patients.”