Pfizer gets European nod for breast cancer treatment Talzenna

New Delhi: Drugmaker Pfizer Inc recently announced that the European Commission has approved TALZENNA (talazoparib) for BRCA-mutated advanced breast cancer in previously-treated patients.

Talzenna (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, is approved as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC).

The drug is also used for patients with hormone receptor-positive (HR+) breast cancer should have been treated with prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. This approval follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018.

Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.

Commenting on the approval, Andreas Penk, M.D., Regional President, Oncology International Developed Markets at Pfizer said, “Today’s approval of TALZENNA for certain patients with advanced-stage breast cancer and an inherited BRCA mutation is the latest example of our successful precision medicine approach to drug development.”

“This important milestone builds on Pfizer’s decades-long legacy of developing therapies that improve outcomes for patients with breast cancer. We are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily, alternative treatment to chemotherapy,” Penk added.

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The European Commission’s approval of TALZENNA, which was acquired as part of Pfizer’s acquisition of Medivation, is based on results from the EMBRACA trial - the largest Phase 3 study of a PARP inhibitor in gBRCA-mutated, HER2- LA or MBC.

The global trial evaluated once-daily TALZENNA compared to physician’s choice standard chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine) in patients with an inherited BRCA1/2 mutation in triple-negative or HR+/HER2- LA or MBC who may have received up to three prior cytotoxic chemotherapy regimens for their advanced disease.

The primary endpoint was progression-free survival (PFS), as assessed by blinded independent central review (BICR). Secondary endpoints from the EMBRACA trial included objective response rate (ORR), overall survival (OS) and safety.

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