Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Inavolisib
New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of anti-cancer drug Inavolisib.
This came the drug major Roche presented Phase III Clinical Study Protocol no. WO44263. The study is to evaluate the efficacy and safety of Inavolisib in combination with Phesgo versus placebo in combination with Phesgo in participants with PIK3CA-Mutated HER2-Positive locally advanced or metastatic breast cancer.
Inavolisib is an oral therapy with high in vitro potency and selectivity for PI3Kα inhibition and the ability to specifically trigger the breakdown of mutant PI3Kα protein. With this unique dual mechanism of action, inavolisib may provide well-tolerated, durable disease control and potentially improved outcomes for people with HR-positive/HER2-negative, PIK3CA-mutated advanced breast cancer. PIK3CA mutations can lead to mutated PI3Kα protein which contributes to uncontrolled tumor growth, disease progression, and resistance to endocrine-based treatment.
Inavolisib is currently being investigated in three Phase III clinical studies in people with PIK3CA-mutated metastatic breast cancer (INAVO120, INAVO121, INAVO122) in various combinations.
At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the Phase III clinical study protocol of the anti-cancer drug Inavolisib presented by drug major Roche.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
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