The U.S. FDA on Thursday approved tarlatamab, a drug for adults with advanced stages of small cell lung cancer.
The drug made by Amgen and marketed under the name Imdelltra is part of Amgen’s pipeline of bispecific antibodies. These designs bring cancer and immune cells together, enabling the body’s immune system to kill the cancer.
Tumours shrank in 40% of patients receiving 10 mg of tarlatamab by intravenous infusion every two weeks, show results from a mid-stage trial published last year in the New England Journal of Medicine.
Amgen said the U.S. price for Imdelltra is $31,500 for the first cycle, and $30,000 for subsequent cycles. The company said trial patients were on the treatment for a median of over five months. This would equate to a commercial price of about $166,500.
Patients in the study lived for a median of 14.3 months, compared with a typical survival rate of about five months.
Most lung cancer cases are non-small cell. The American Cancer Society says 15 per cent are the more aggressive small cell variety, targeted by Imdelltra.
The disease impacts about 35,000 U.S. patients annually. It is “one of most rapidly proliferating and most aggressive cancers there is,” said Jay Bradner, Amgen’s chief scientific officer.
Amgen said it will need to complete its larger, pivotal trial in advanced small cell lung cancer to receive full FDA approval of the drug.
Moreover, the drug is also being tested on some patients with earlier-stage small cell lung cancer.
(REUTERS)
