Entries by old admin

Like the Phoenix, Aducanumab Rises

October 31, 2019 Impact: High In March this year, the aducanumab phase 3 Alzheimer’s disease trials were stopped based on futility, meaning that it was statistically almost impossible for the study to meet its endpoint. The operative word was apparently “almost.” Full analysis of the phase 3 results now shows that the high dose arm […]

Keytruda Monotherapy Approved for 1L PD-L1-Positive NSCLC in China

October 11, 2019 Impact: High Merck has announced that the China NMPA (National Medical Products Administration) has approved the use of Keytruda (pembrolizumab) as a frontline monotherapy agent in patients with locally advanced or metastatic NSCLC tumors with PD-L1 expression of at least 1% (TPS ≥1%, determined by an NMPA-approved test), without EGFR or ALK […]

Keytruda/Lenvima Combination Receives Accelerated Approval for 2L+ Endometrial Carcinoma

October 1, 2019 Impact: High Merck and Eisai have announced that FDA has granted an accelerated approval to the combination treatment of Keytruda/Lenvima (pembrolizumab/lenvatinib) for patients with advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient), who have disease progression following prior systemic therapy and are not candidates for curative […]