Amgen, Takeda cancer drug trials stopped after deaths
NEW YORK Several deaths have brought phase 3 clinical trials of a cancer drug by Amgen and Takeda Pharmaceutical to a halt.
The two companies are investigating the drug, motesanib, as an initial treatment for small-cell lung cancer, to be used in conjunction with chemotherapy.
A committee monitoring the 600-patient study found more had died early using the drug than those receiving placebo.
“While we are disappointed in the outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents,” Amgen executive vice president for research and development Roger Perlmutter said in a statement.
FDA, SciClone meet agreement on distribution of melanoma treatment
NEW YORK The Food and Drug Administration has reached an agreement with a drug maker on the design of a phase 3 trial of a skin cancer drug.
SciClone Pharmaceuticals announced Monday that it had reached the agreement with the agency concerning the drug thymalfasin, which it sees as a potential treatment for stage 4 melanoma.
“Patients suffering from stage 4 melanoma have very few treatment options available,” SciClone chief medical officer Israel Rios said in a statement. “Based on the positive data from an earlier phase 2 trial, thymalfasin could provide new treatment modalities for this high unmet medical need.”
The drug, if approved, will be sold under the brand name Zadaxin. The full name of its active ingredient is thymosin alpha 1.
Teva releases generic version of AstraZeneca’s Pulmicort
NORTH WALES, Pa. The world’s largest maker of generic drugs has introduced a generic version of AstraZeneca’s Pulmicort Respules.
Teva announced Wednesday that it had launched budesonide inhalation suspension, a treatment for asthma, in 0.25-mg-per-2-milliliters and 0.5-mg-per-2-milliliter strengths.