gdc
FDA Approvals, News & UpdatesLeukemiaNewsworthy

Tibsovo First Drug Approved by the FDA for AML with IDH1 Mutation

In July 2018, the FDA approved Tibsovo (ivo-sidenib; from Agios Pharmaceuticals), the first IDH1 inhibitor, for the treatment of adults with relapsed (returning) or refractory (not responding to treatment) acute myeloid leukemia (AML) and a susceptible IDH1 genetic mutation.
October 2018 Vol 4 No 5 – October 17, 2018

In July 2018, the FDA approved Tibsovo (ivo-sidenib; from Agios Pharmaceuticals), the first IDH1 inhibitor, for the treatment of adults with relapsed (returning) or refractory (not responding to treatment) acute myeloid leukemia (AML) and a susceptible IDH1 genetic mutation. On the same day, the FDA approved the RealTime IDH1 test, which is designed to identify the IDH1 mutation. Tibsovo should be used in patients after they had the RealTime IDH1 genetic test to confirm that they have that mutation.

“Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”

This approval was based on a clinical trial of 174 adults with relapsed or refractory AML and a confirmed IDH1 mutation. In about 32% of the patients, the cancer was in complete remission after receiving Tibsovo. It took an average of 2 months to respond to this treatment, and the remission lasted an average of 8.2 months.

Among the most common side effects with Tibsovo were fatigue, increase in white blood cells, joint inflammation/pain, diarrhea, shortness of breath, nausea, mucositis, fever, cough, and constipation.

Recommended For You
Financial SupportLeukemiaPatient Stories
There’s No Place Like Home: How a Visit to the United States Saved My Life
By Martin Miralda
Martin Miralda was fresh out of college when a short visit to the United States helped to save his life after he was diagnosed with leukemia. Despite his lacking health insurance as a non-resident, he received superior medical care through “Charity Care,” a service that covers necessary hospitalization for uninsured people in the country and is available in several states.
Breast CancerFDA Approvals, News & UpdatesImmunotherapy
First Immunotherapy Approved for Patients with Advanced or Metastatic Triple-Negative Breast Cancer Expressing PD-L1
In March 2019, the FDA approved Tecentriq (atezolizumab), a PD-L1 inhibitor, in combination with Abraxane (paclitaxel protein-bound), for use in adults with locally advanced or metastatic triple-negative breast cancer whose tumors cannot be removed by surgery and express PD-L1, as identified by an FDA-approved test. This is the first FDA-approved immunotherapy for patients with advanced or metastatic triple-negative breast cancer.
FDA Approvals, News & UpdatesGastric Cancer
Lonsurf Approved for Metastatic Gastric or Gastroesophageal Junction Cancer
In February 2019, the FDA approved Lonsurf for the treatment of patients with metastatic gastric (stomach) cancer or gastroesophageal junction adenocarcinoma. This drug was previously approved only for patients with metastatic colorectal cancer.
Last modified: October 27, 2018

Subscribe to CONQUER: the patient voice® magazine

Receive timely cancer news & updates, patient stories, and more.

Country