1st Immunotherapy for Breast Cancer Treatment Approved
FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq ® (atezolizumab) plus chemotherapy (Abraxane ®) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
This immunotherapy is approved for people whose tumors express PD-L1, as determined by an FDA-approved test.
This is important news, since approximately 271,000 people in the USA will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019, says the American Cancer Society.
This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Hayley Dinerman, executive director of the Triple Negative Breast Cancer Foundation said in a press release, “Chemotherapy alone has been the mainstay of treatment for many years, so it’s encouraging to now have an immunotherapy combination available for people with PD-L1-positive disease.”
This accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40 percent compared with nab-paclitaxel alone (median PFS=7.4 vs. 4.8 months; HR=0.60, 95% CI: 0.48-0.77, p<0.0001) in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Overall survival (OS) results were immature with 43 percent of events in all randomized patients (intent-to-treat; ITT), and further data will be shared with the FDA and presented at an upcoming medical meeting.
Safety in the Tecentriq plus nab-paclitaxel arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.
The most common Grade 3-4 side effects (≥2 percent) with Tecentriq plus nab-paclitaxel were low white blood cells, tingling or numbness in the hands and feet, neutrophil count decreased, feeling tired, low red blood cells, low blood potassium level, pneumonia and increased blood level of a liver enzyme.
The most common side effects (≥20 percent) were hair loss, feeling tired, tingling or numbness in the hands and feet, nausea, diarrhea, low red blood cells, constipation, cough, headache, low white blood cells, decreased appetite and vomiting.
For those who qualify, Genentech offers patient assistance programs for people prescribed Tecentriq by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit Genentech-Access/Tecentriq for more information.
- FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic
- Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
- Phase III IMpassion130 Study Showed Genentech's TECENTRIQ Plus Abraxane Significantly Reduced the Risk of Disease Worsening