07/10/2018

Recent Oncology Related Drug News

FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients

From the American Society of Clinical Oncology: In cooperation with the Food and Drug Administration (FDA), and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA to inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, ASCO does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

The Agency took this action on June 19, 2018, due to decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

The labels of both drugs have been revised to reflect the limitation in the indication. The indications read as follows:

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

• Are not eligible for cisplatin-containing therapy, and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), as determined by an FDA-approved test, or
• Are not eligible for any platinum-containing therapy regardless of PD-L1 status.

On July 2, 2018, the FDA approved the Ventana PD-L1 (SP142) Assay^® (Ventana Medical Systems, Inc.) for PD-L1 expression in ≥ 5% IC in urothelial carcinoma tissue. The test should be used to select patients with locally advanced or metastatic urothelial carcinoma for treatment with atezolizumab (Tecentriq,^® Genentech Inc.). The FDA also updated the Prescribing Information for Tecentriq to require use of an FDA-approved test for patient selection.

The tests used in the trial to determine PD-L1 expression are listed in Section 14 of each drug label. The FDA is reviewing the findings of ongoing analyses and will communicate new information regarding the PD-L1 assays and indications as it becomes available.

Tecentriq Prescribing Information

Keytruda Prescribing Information

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

Follow the Oncology Center of Excellence on Twitter @FDAOncology.

Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology.

Drug Discount Program: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement

GAO-18-480, June 21

• Report: https://www.gao.gov/products/GAO-18-480
• Highlights: https://www.gao.gov/assets/700/692695.pdf