Study: AstraZeneca Drug Improves Survival In Breast Cancer Patients
Late-stage trials find that Enhertu benefits patients with HER2-positive metastatic breast cancer. Separately, Fierce Pharma reported Friday that the drug also won accelerated approval in patients with HER2-mutant non-small cell lung cancer (NSCLC) who have received a prior systemic therapy, making it the first drug specifically approved for that condition, according to the FDA.
Reuters:
AstraZeneca Says Data Confirms Enhertu Benefit In Breast Cancer Patients
AstraZeneca said a late-stage trial had confirmed the benefit of breast cancer drug Enhertu in patients with an advanced form of the disease who had been previously treated with another therapy. (Grover and Aripaka, 8/15)
FiercePharma:
AstraZeneca's Enhertu Wins Approval In HER2-Mutant Non-Small Cell Lung Cancer
AstraZeneca and Daiichi Sankyo's Enhertu is on fire with two key FDA approvals in as many weeks. Friday, the drug scored an accelerated approval in patients with HER2-mutant non-small cell lung cancer (NSCLC) who have received a prior systemic therapy. With the nod, the HER2-directed antibody drug conjugate becomes the first drug specifically approved for HER2-mutant NSCLC, the FDA says. (Becker, 8/12)
In other pharmaceutical developments —
FiercePharma:
Two Zolgensma Deaths Bring Gene Therapy Safety To Spotlight
Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention. Two children in Russia and Kazakhstan died about five to six weeks after receiving Zolgensma, Novartis confirmed to Fierce Pharma. Both patients died of acute liver failure, a known side effect of Zolgensma that’s included in a boxed warning on the one-time therapy’s label. Both had received corticosteroids to restore liver function. (Liu, 8/12)
NBC News:
Fungal Infections Are Developing Drug Resistance
Aspergillus and another fungus, Candida auris, are growing resistant to the treatments frequently used to fight them — in particular, a class of drugs called azoles. "If we lose that drug class because of resistance, we’re in for big trouble," said Darius Armstrong-James, an infectious disease physician at Royal Brompton Hospital in the U.K. (Bendix, 8/13)
NBC News:
Fitness Influencers Pull Back The Curtain On Steroid Use Among Bodybuilders
The once-taboo topic of anabolic steroid use in the fitness and bodybuilding communities has become its own internet content genre. (Traylor, 8/13)