Pemetrexed

Oncologists recommend waiting for PD-L1 test results before initiating treatment in metastatic NSCLC patients without visceral crisis, as PD-L1 status guides immunotherapy selection.

A phase 2 trial demonstrated that BNT327/PM8002 plus chemotherapy achieved a 51.6% confirmed overall response rate in 31 patients with unresectable pleural and peritoneal mesothelioma.

Daiichi Sankyo and Merck voluntarily withdrew their Biologics License Application for patritumab deruxtecan in EGFR-mutated NSCLC after the confirmatory HERTHENA-Lung02 Phase 3 trial failed to demonstrate statistically significant overall survival benefit.

• Novocure's Optune Lua device has received CE Mark approval for treating metastatic non-small cell lung cancer (NSCLC) when used concurrently with immune checkpoint inhibitors or docetaxel in patients who have progressed on platinum-based therapy. • The Phase 3 LUNAR trial demonstrated a significant 3.3-month extension in median overall survival, with patients receiving Optune Lua plus an immune checkpoint inhibitor showing a remarkable 7.7-month survival benefit compared to immune checkpoint inhibitor alone. • Optune Lua delivers Tumor Treating Fields (TTFields) through wearable arrays, using electric fields to physically disrupt dividing cancer cells without significant systemic toxicity, representing the first substantial survival improvement for this patient population in over eight years.

CMS has begun issuing unique J-codes to 505(b)(2) drugs as of January 2023, fundamentally changing how these medications are reimbursed and potentially affecting 943 approved drugs dating back to 2003.