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Regulator OKs Pfizer's BRCA mutation breast cancer treatment
  • By Lee Han-soo
  • Published 2020.08.05 16:02
  • Updated 2020.08.05 16:02
  • comments 0

Pfizer Korea said that the Ministry of Food and Drug Safety has approved Talzenna, its BRCA (Breast Cancer Susceptibility Gene) mutation breast cancer targeted therapy.

Pfizer Korea has received product approval for Talzenna, a breast cancer treatment, from the Food and Drug Safety Ministry. (Pfizer Korea)

Talzenna is an oral poly ADP-ribose polymerase (PARP) inhibitor that inhibits PARP1 and PARP2, playing an essential role in DNA repair. As a result, it induces cell death by interfering with DNA repair of cancer cells with gBRCA mutation.

With the regulatory nod, hospitals can use the treatment as monotherapy for germline BRCA (gBRCA) mutations and HER2 (human epithelial cell growth factor receptor 2) negative locally advanced or metastatic breast cancer patients have previously had chemotherapy.

The ministry's approval comes after the company confirmed the safety and efficacy of the treatment through a global phase 3 trial, also known as EMBRACA.

In the clinical trial, the median progression-free survival (mPFS), which was the primary endpoint, was 8.6 months in the Talzenna-administered group, which was an improvement from 5.6 months in the chemotherapy group.

Also, the Talzenna-administered group showed a 46 percent lower risk of disease progression or death than the chemotherapy group.

Such a PFS improvement effect was also significant in the significant subgroups affecting the prognosis of breast cancer treatment, including triple-negative breast cancer patients, hormone receptor (HR) positive patients, and central nervous system (CNS) metastasis history patients.

The trial data on objective response rate (ORR), which was the secondary endpoint, also showed 62.2 percent for the Talzenna-administered group, which was more than double the amount of the 27.2 percent ORR in the chemotherapy group.

"We are very pleased to be able to provide treatment options to patients with breast cancer in Korea through the local sales license of Talzenna," said Managing Director Song Chan-woo in charge of Pfizer's Asian oncology business unit.

Song added that Pfizer Korea would continue to make efforts to present improved treatment options to patients and medical staff and bring meaningful changes to patients' lives through innovative treatments for breast cancer and various carcinomas.


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