Last Updated on October 11, 2024 by The Health Master
Bengaluru: The U.S. Food and Drug Administration (USFDA) approved Mirati Therapeutics Inc.’s lung cancer drug adagrasib, sending its shares up more than 8 percent in extended trading.
Mirati’s drug has been approved for treating adult patients with advanced lung cancer as determined by an USFDA-approved test, who have received at least one prior systemic therapy.
Adagrasib, an oral drug, is designed to target a mutated form of a gene known as KRAS that occurs in about 13 percent of non-small cell lung cancers (NSCLC), the most common form of the disease, and less frequently in some other solid tumors.
Mirati said the drug will be sold under the brand name Krazati at a price of $19,750 for a 200-milligram tablet and a 180-count bottle.
Another KRAS inhibitor, Amgen Inc.’s Lumakras, is already available to treat patients suffering from advanced lung cancer as a second-line therapy after initial therapy fails or stops working.
Lumakras, which was approved last year, sold $75 million in the third quarter.
David Meek, Chief Executive, Mirati said in a recent interview that the drug is a compelling choice.
“I think physicians and patients are going to appreciate having an effective option,” he said, noting that 43 percent of second-line trial patients responded to adagrasib.
Shares of Mirati have fallen about 55 percent since early this month, after the company’s presentation of early data from studies of adagrasib in combination with Merck & Co.’s immunotherapy Keytruda as an initial treatment for metastatic NSCLC.
The results showed that the combination helped about half of the trial participants. But Mirati said it would first move to a trial only in patients with lower levels of the protein targeted by Keytruda, with a high bar for proving superiority over the standard of care.
Wall Street analysts, initially encouraged by the efficacy and safety findings, questioned Mirati’s strategy for future combination studies.
“We see a long and challenging path to Phase 3 data, and the possibility for an acquisition is likely off the table for now,” BMO Capital Markets analyst Evan Seigerman said in a research note before the approval.
USFDA gives nod for Silodosin, Pregabalin Capsules
USFDA gives final approval for Desonide cream
USFDA gives nod for Diclofenac Sodium topical solution
USFDA gives approval for Venlafaxine ER tablets
USFDA gives nod for Levothyroxine Sodium For Injection
USFDA gives nod for Nifedipine ER tablets
International drug racket busted in Hyderabad, two held
Drug alert: 83 out of 1487 samples declared as NSQ in November 20222
FDA: Patients cannot be forced to buy medicines from hospital-attached pharmacies
Pharmacy education needs to adopt 2D, 3D format for lectures
Indian Pharma Companies have potential in Saudi Arabia
USFDA gives nod for Silodosin, Pregabalin Capsules
Parliament panel recommendation for National Commission on Medical Devices
Homoeopathy: Commission notifies BHMS Regulations 2022
USFDA gives final approval for Desonide cream
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
