Patients with endocrine-resistant, HER2-negative, locally advanced or metastatic breast cancer can use the treatment after ...
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K ...
The FDA also approved the FoundationOne Liquid CDx assay to identify patients who qualify for the newly approved treatment.
Medpage Today on MSN6d
PI3K Inhibitor Wins FDA Approval for Advanced Breast CancerThe FDA approved the PI3K-pathway inhibitor inavolisib (Itovebi) for use in combination with palbociclib (Ibrance) and ...
As Roche comes under competitive pressure on its breast cancer business, the Swiss company hopes a new drug will add a ...
Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination ...
Itovebi is supplied as a tablet in 2 dosage strengths: 3mg and 9mg. Patients should be selected for treatment based on the presence of 1 or more PIK3CA mutations in plasma specimens. The FDA has ...
The approval of inavolisib is supported by findings from the phase 3 INAVO120 study evaluating the agent plus palbociclib and ...
Approval is based on Phase III INAVO120 results, showing the Itovebiâ„¢ (inavolisib)-based regimen more than doubled ...
The Food and Drug Administration (FDA) has approved Itovebi (inavolisib) with Ibrance (palbociclib) and Faslodex (fulvestrant ...
The FDA has approved Itovebi in combination with palbociclib and fulvestrant to treat certain patients with PIK3CA-mutant breast cancer.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug ...
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