Merck, Daiichi Sankyo Say FDA Grants Priority Review In U.S. For Patritumab Deruxtecan
(RTTNews) - Merck & Co. Inc. (MRK) and Japan's Daiichi Sankyo Co. Ltd. (DSKYF.PK) announced Friday that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.
Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck.
The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial.
read more
Merck Q2 Results Top Estimates, But Slashes FY24 Earnings Outlook
Biopharmaceutical company Merck & Co., Inc. (MRK) reported Tuesday a net profit for the second quarter compared to a loss last year, reflecting improved gross margins and a 7 percent sales growth. Both adjusted earnings per share and quarterly sales topped analysts' estimates. However, the company slashed its adjusted earnings guidance for the full-year 2024.
RTTNews
|
il y a 112
Ligand Says Merck Receives FDA Approval For CAPVAXIVE For Adults
Ligand Pharmaceuticals Inc. (LGND) announced Tuesday that its collaborator Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for CAPVAXIVE, previously known as V116, a 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population.
RTTNews
|
il y a 154
Merck Begins Phase 3 Trial Of MK-1084 As First-Line Treatment Of Certain Metastatic NSCLC Patients
Merck & Co. Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Thursday it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1.
RTTNews
|
il y a 229
Merck Says Health Canada Oks KEYTRUDA In Combination With Trastuzumab And Chemotherapy
Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, announced Monday that Health Canada has granted approval of KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 as determined by a validated test.
RTTNews
|
il y a 281
Merck Guides FY24 EPS Above Estimates As Q4 Results Top Estimates
Biopharmaceutical company Merck reported Thursday a net loss for the fourth quarter compared to a profit last year, hurt by hefty charge, despite 6 percent sales growth. However, both adjusted earnings per share and quarterly sales topped analysts' estimates.
RTTNews
|
il y a 292
Merck Q4 Results Top Estimates; Guides FY24 Adj. EPS Above Estimates
Biopharmaceutical company Merck & Co., Inc. (MRK), known as MSD outside the U.S. and Canada, reported Thursday a net loss attributable to the company for the fourth quarter of $1.23 billion or $0.48 per share, compared to net income of $3.02 billion or $1.18 per share in the prior-year quarter.
RTTNews
|
il y a 292
Esperion Therapeutics, Daiichi Sankyo Europe Ink $125 Mln Amendment To Their Collaboration
Esperion Therapeutics, Inc. (ESPR) and Daiichi Sankyo Europe GmbH or DSE, the European arm of Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. (DSKYF.PK), announced Wednesday a $125 million amendment to their collaboration, which includes an amicable resolution to their commercial dispute and certain other adjustments to enhance the long-term value of their products.
RTTNews
|
il y a 321
Merck Says Phase 3 LEAP-001 Trial Evaluating KEYTRUDA Plus LENVIMA Did Not Meet Endpoints
Merck & Co., Inc. (MRK), known as MSD outside of the U.S. and Canada, and Japan's Eisai Co. Ltd. (ESALY.PK, ESALF.PK) announced Friday that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.
RTTNews
|
il y a 347
