How Effective is Pralsetinib?

Pralsetinib is the sixth drug under Genentech that has obtained FDA approval for the treatment of lung cancer.

How Effective is Pralsetinib?

The FDA has granted this drug Breakthrough Therapy Designation, with two indications:

For the treatment of RET fusion-positive non-small cell lung cancer (NSCLC) in patients whose disease has progressed after platinum-based chemotherapy.

For the treatment of RET mutation-positive medullary thyroid carcinoma (MTC) in patients who require systemic therapy and have no other suitable alternative treatment options.

In addition, Pralsetinib has also been granted Priority Review by the FDA for patients with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer, with a decision on approval expected by February 28, 2021. The New Drug Application (NDA) was submitted through the FDA’s Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to establish a more efficient drug review mechanism to accelerate the availability of safe and effective therapies for patients.

Use of Pralsetinib in Special Populations

Exposure of the unborn fetus to this drug may cause birth defects. Therefore, patients should not become pregnant or impregnate others while taking this drug.

Female patients must use effective non-hormonal contraception during treatment and for at least 2 weeks after the end of treatment.

Male patients should use appropriate contraception during treatment and for 1 week after the last dose. Even if your menstrual cycle has stopped or you think you are not producing sperm, you may still be fertile and able to conceive.

Breastfeeding is not recommended during treatment with this drug and for 1 week after the last dose.

Drug Interactions of Pralsetinib

Avoid concomitant use of Pralsetinib with any of the following drugs:

1. Potent CYP3A inhibitors, e.g., ritonavir

2. Moderate CYP3A inhibitors, e.g., amlodipine

3. P-gp inhibitors, e.g., clarithromycin

4. Dual P-gp and potent CYP3A inhibitors, e.g., verapamil

5. Dual P-gp and moderate CYP3A inhibitors, e.g., amiodarone

If concomitant use with any of the above inhibitors is unavoidable, the current dose of Pralsetinib should be reduced in accordance with the recommendations in the prescribing information. Resume the dose of Pralsetinib that was administered prior to the initiation of the concomitant inhibitor 3–5 elimination half-lives after discontinuation of the inhibitor.