Oncology

The conversion from accelerated to traditional approval was based on data from the phase 3 innovaTV 301 clinical trial.

The approval of Hercessi was based on a comprehensive package of analytical, preclinical, and clinical data demonstrating that the biosimilar product is highly similar to the reference product, Herceptin.

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4 and vascular endothelial growth factor A.

No increased risk for thyroid cancer seen with use of GLP1 receptor agonist versus DPP4 inhibitor use, SGLT2 inhibitor use.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dostarlimab-gxly in combination with standard of care chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors. The sBLA is supported by data from part…

Ojemba is an oral, brain-penetrant, highly-selective type II RAF kinas inhibitor designed to target a key enzyme in the MAPK signaling pathway.

The expanded approval was based on PK, dosimetry, and safety data from the phase 2 NETTER-P study which included 9 pediatric patients, of which 4 patients had GEP-NETs.

Aspirin users have nodal metastases significantly less often, higher infiltration of tumor-infiltrating lymphocytes.

The approval was based on data from the phase 3 ALINA study, which included 257 adults with ALK-positive NSCLC (tumors ≥4cm or node positive) following complete tumor resection.

The updates were prompted by findings from an investigation of reports describing mature T-cell malignancies among patients treated with these therapies.

In restricted sample using propensity score adjustment, significant association only seen for serrated polyps

The approval was supported by data from the randomized, intra-patient controlled INSITE trial.

One in 5 patients with cancer participate in any cancer-related trial, including biorepository, registry, genetic, and quality-of-life studies.

A record high of 323 different meds were in short supply during the first quarter of 2024,

Lower prevalence of mammogram seen for women with three or more versus no adverse social determinants of health, health-related social needs

The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of March. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on eMPR.com. Key: D=Dosing,…