FDA Approves a Number of Cancer Drugs that Show Great Promise


The Food and Drug Administration, the U.S.A. agency tasked with regulating and overseeing all medical developments, has given green light to a series of cancer-fighting drugs and treatments.

First on the list is iobenguane I-131, marketed as Azedra, a drug for advanced or metastatic pheochromocytoma or paraganglioma. It uses UltraTrace and has the advantage of delivering greater levels of radiation directly to the tumor.

The Magtrace and Sentimag Magnetic Localization System is a guiding tool, also newly approved by the FDA. It detects magnetic Magtrace particles that are injected right into the breast tissue, where they remain trapped in the lymph nodes. The system is as effective as traditional scanners but less invasive.

Filgrastim-aafi (Nivestym) is a biosimilar designed to help with the adverse effects of cancer treatment, especially febrile neutropenia and severe neutropenia. It is recommended for patients suffering from acute myeloid leukemia or chronic congenital, cyclic, or idiopathic neutropenia.

For cases of acute myeloid leukemia, there is a new drug, Ivosidenib (Tibsovo). It showed a complete remission rate of 24.7% and an improvement in median duration of CR and CRh from 2 months to 8.2 months.

The combination of lenvatinib and pembrolizumab, a treatment for advanced and/or metastatic non–microsatellite instability-high/proficient mismatch repair endometrial carcinoma, was awarded Breakthrough Therapy designation. The Study 111/KEYNOTE-146 trial, which showed a median PFS of 7.4 months, was the basis for this classification.

Finally, the quizartinib treatment for adults with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia also received Breakthrough Therapy designation. The phase III QuANTUM-R study revealed a reduction in risk of disease progression or death by 24%, thanks to the use of the FLT3 inhibitor. The median overall survival went from 4.7 to 6.2 months.

It’s hard not to get over enthusiastic seeing so many new treatments and medication dedicated to fighting cancer.