Pfizer Recalls Chantix Anti-Smoking Drug Over Cancer-Causing Chemical
The voluntary recall was driven by the presence of high levels of nitrosamine, which can increase the risk of cancer. Separately, a study showed a Mirati Therapeutics drug that blocks the KRAS cancer protein shrank tumors in 22% of patients with advanced colon cancers.
USA Today:
Chantix Recall: Pfizer Recalls Smoking Cessation Drug For Cancer Risk
Pfizer is voluntarily recalling all lots of its popular anti-smoking drug Chantix for high levels of nitrosamine, which can increase the risk of cancer. According to the notice posted on the Food and Drug Administration website, the recall is for all lots of 0.5 mg and 1 mg varenicline tablets. The recall notice says that long-term ingestion can lead to a "potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication." (Tyko, 9/17)
Stat:
New Colon Cancer Study Suggests Mirati Has The Best KRAS-Blocking Drug
A drug from Mirati Therapeutics designed to block the cancer protein called KRAS shrank tumors in 22% of patients with advanced colon cancer, according to results from a clinical trial presented Sunday. When the Mirati drug, a pill called adagrasib, was combined with another targeted medicine, the colon cancer response increased to 43%. The adagrasib study results are the strongest reported to date for a new class of cancer drugs that work by blocking the effects of a specific type of KRAS alteration called G12C. The Mirati drug is potentially superior to a competing drug from Amgen that won U.S. approval in May to treat patients with KRAS-targeted lung cancer. (Feuerstein, 9/19)
In legal news —
AP:
Use Of OxyContin Profits To Fight Opioids Formally Approved
A judge formally approved a plan Friday to turn OxyContin maker Purdue Pharma into a new company no longer owned by members of the Sackler family and with its profits going to fight the opioid epidemic. U.S. Bankruptcy Judge Robert Drain officially confirmed the reorganization Friday, more than two weeks after he announced he would do so pending two largely technical changes to the plan presented by the company and hashed out with lawyers representing those with claims against the company. (Mulvihill, 9/17)
Stat:
Former Mylan IT Exec Pleads Guilty To Insider Trading
A former Mylan information technology executive pleaded guilty to an insider trading scheme in which he acted on tips from another executive ahead of public announcements about earnings, drug approvals, and a pending merger with a Pfizer (PFE) division. In court documents, the U.S. Securities and Exchange Commission alleged that Dayakar Mallu, 51, was tipped by an unnamed senior manager at Mylan and acted on the information four separate times between September 2017 and July 2019. In exchange for the inside information, the former Mylan executive shared a portion of the profits with the manager through cash transactions in India. (Silverman, 9/19)
