Radiation May Be Redundant For Early-Stage Breast Cancer Patients
A study found that treatment with mastectomy, lymph-node surgery, and advanced anti-cancer drugs was sufficient for survival among women with early-stage breast cancer. Other news is on pancreatic cancer drugs, FDA warnings on unapproved botox, and more.
Radiation has long played a role in the treatment of breast cancer, though doctors have used it more sparingly in early-stage disease in recent years, as advances in diagnostics and treatment have improved survival rates. Now a new study with an unusually long follow-up period has found that radiation to the chest wall made absolutely no difference in survival among women with early-stage breast cancer who had been treated with mastectomy, lymph-node surgery and advanced anti-cancer drugs. (Caryn Rabin, 11/5)
At 69 years old, Debby Orcutt was diagnosed last year with pancreatic cancer, a condition so dire that her doctor refused to tell her how long she had to live. With few good options, she enrolled in a clinical trial for an experimental drug. 鈥淚 just looked at it like, what have I got to lose?鈥 she said. 鈥淚鈥檓 gonna die.鈥 A scan last week showed her tumor had shrunk 64 percent since starting the drug in January, according to her husband. It is the sort of clinical evidence that is stirring optimism and has prompted the Trump administration to put it on a novel path for rapid approval. (Gilbert, 11/5)
A new study found links between a toxic dry cleaning chemical and liver cancer. Trump officials are reconsidering an EPA plan to phase it out. (Ajasa, 11/6)
Those silver strands could be an outward sign of the body鈥檚 own intricate defenses against cancer, a recent study in mice has shown. (Stebbing, 11/5)
This month, tens thousands of white flags have been planted on the National Mall to memorialize the 120,000 Americans who die from lung cancer every year. (Segraves, 11/5)
In other pharma and tech news 鈥
U.S. health regulators on Wednesday sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth wrinkles. The Food and Drug Administration said it was taking action after receiving reports of injuries in connection with the products, including toxic side effects. Botox is a diluted, purified form of botulinum, one of the most toxic substances in the world. The ingredient works by temporarily blocking nerve signals and causing muscles to relax. (Perrone, 11/6)
The FDA approved linaclotide (Linzess) capsules to treat irritable bowel syndrome with constipation (IBS-C) in children age 7 years and older, the agency announced Wednesday. The decision makes the guanylate cyclase-C agonist the first treatment approved for IBS-C in pediatric patients, with a recommended dose of 145 碌g orally once daily per linaclotide's updated label. (McCreary, 11/5)
A judge denied Pfizer Inc.鈥檚 request to temporarily block Novo Nordisk A/S鈥 $10 billion bid to acquire the obesity startup Metsera Inc., saying the US pharmaceutical company鈥檚 objections to the deal don鈥檛 warrant a delay. Delaware Chancery Judge Morgan Zurn concluded Wednesday that Pfizer didn鈥檛 level legitimate complaints about Novo鈥檚 effort to supplant it as New York-based Metsera鈥檚 buyer and refused to bar the Danish company from proceeding with the transaction. (Feeley, 11/5)
Dexcom recalled its Android app for G6 and G6 Pro continuous glucose monitoring systems due to a software flaw that can cause it to shut down unexpectedly. The Food and Drug Administration labeled the action a Class I recall, the most serious kind. The issue means the user might not receive estimated glucose values, alarms, alerts or notifications, the FDA said. This could lead to a failure to detect a hyperglycemic or hypoglycemic event, potentially resulting in severe hyperglycemia, diabetic ketoacidosis or a hyperosmolar hyperglycemic state, the agency said. (Dubinsky, 11/5)