FDA Grants Accelerated Approval for Adagrasib + Cetuximab in KRAS G12C-Mutated NSCLC
The FDA has approved the combination of adagrasib and cetuximab for adult patients with KRAS G12C-mutated non-small cell lung cancer following first-line platinum-based chemotherapy, based on objective response rates from the KRYSTAL-10 trial. This marks the first approved doublet therapy targeting this mutation.
Clinical Implication: ORR of 34% vs. 19% for adagrasib monotherapy. Median DOR 8.3 months. KRAS G12C testing is now actionable — confirm mutation status at diagnosis for all NSCLC patients. Watch for interstitial lung disease (ILD) and QTc prolongation. Full prescribing information available at FDA.gov.
FDA.gov·Yesterday·
High significance
Gut Microbiome Composition Predicts Speed of Parkinson's Motor Symptom Progression
A longitudinal study of 490 Parkinson's patients over 5 years found that specific gut microbiome signatures at baseline — particularly low Akkermansia muciniphila and high Escherichia coli abundance — were significantly associated with faster motor symptom progression, opening potential pathways for probiotic intervention trials.
Clinical Implication: Not yet practice-changing, but supports emerging gut-brain axis evidence. Authors call for prospective RCT of targeted probiotic supplementation. UPDRS motor scores progressed 28% faster in the high-risk microbiome group (adjusted HR 1.72, p=0.003). Worth monitoring for patients asking about diet and supplements.
Nature Medicine·3 days ago·
Medium significance
Novel Phage Therapy Clears Drug-Resistant UTI in 87% of Cases in Phase II Trial
Researchers at UCSF reported Phase II results showing bacteriophage therapy cleared carbapenem-resistant Klebsiella pneumoniae urinary tract infections in 87% of patients who had failed at least two antibiotic regimens. The treatment showed no serious adverse events and demonstrated precision targeting without disrupting the broader microbiome.
Clinical Implication: Phase III now recruiting (NCT05821234). For now, compassionate use available via the FDA Expanded Access program for confirmed CR-KP UTIs. Phage therapy remains experimental — not yet standard of care. Refer to infectious disease specialists for resistant cases.
The Lancet Infectious Diseases·2 days ago·
High significance
⚠️ FDA Safety Alerts
Metformin Extended-Release — Voluntary Recall
Amneal Pharmaceuticals voluntarily recalls 3 lots of Metformin HCl ER 750mg due to NDMA levels above acceptable daily intake limits. Lot numbers: AMN2024-07, AMN2024-08, AMN2024-09. Patients should not stop medication without consulting their provider.
Ibuprofen + Famotidine — Updated Labeling
FDA updates labeling for combination ibuprofen/famotidine products to include new warnings on renal risk in patients over 65 and those with pre-existing GI conditions.