Patients suffering from deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer now have another treatment option in the form of Talzenna (talazoparib). Produced by Pfizer, one of the biggest pharmaceutical companies in the industry, the drug is only the second PARP (Poly ADP-ribose polymerase) inhibitor released on the market, after Lynparza (olaparib).
The FDA announced that eligibility for this therapy will be based on results from the BRACAnalysis CDx test, a companion diagnostic, also recently approved by the agency.
The decision was based on data from an open-label, phase 3 EMBRACA trial with 431 participants that had received no more than three previous cytotoxic courses. They were randomized and given either 1 mg of Talzenna or physician’s choice of chemotherapy – capecitabine, eribulin, gemcitabine or vinorelbine.
Overall median progression-free survival with Talzenna was 8.6 months compared to 5.6 months in the chemotherapy group.
Some of the most common side effects reported were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea and decreased appetite.
“We congratulate Pfizer on obtaining FDA approval of TALZENNA for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test”, said Lloyd Sanders, president of Myriad Oncology in a press release. “We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test”.
To view the full prescribing information pertaining to Telzenna, click here.