Tag Archive for: monotherapy

The drug would be used to treat adults with a type of advanced lung cancer, AstraZeneca said, adding that the FDA’s approval was based on trials which extended median progression-free survival (PFS) by nearly nine months.

The Swiss pharma’s Fabhalta, a Factor B inhibitor, is the first FDA-approved oral monotherapy for adults with the rare, chronic blood disorder paroxysmal nocturnal hemoglobinuria.

The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.

In a double data drop yesterday, AbbVie touted two clinical trial wins. Topline data from the Phase III INSPIRE study showed Skyrizi (risankizumab) met its primary and all secondary endpoints in ulcerative colitis and Rinvoq (upadacitinib) aced its Phase II SLEek trial, showing therapeutic potential in systemic lupus erythematosus.

The companies said they will co-develop the candidate, ONC-392, as a monotherapy or as a combination therapy in various cancer indications.

After examining the available information and hearing the testimony of CKD patients who participated in the clinical studies, the majority of the committee agreed the benefits of the medication outweighed its risks as a monotherapy.

Merck’s exceptional revenue growth in 2021 and the first half of 2022 came thanks to three big brands, one of which is not even approved by the FDA yet.