Medical

AZ and Merck get FDA breast cancer nod for Lynparza

AZ and Merck get FDA breast cancer nod for Lynparza

Dave Fredrickson, executive vice-president and head of the Oncology Business Unit at AstraZeneca, said: "This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer and the only PARP inhibitor approved beyond ovarian cancer".

As per the FDA reports, this latest approval from the US regulators was based on study trial of 302 women who were diagnosed with BRCA gene mutation and metastatic breast cancer. It is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a BRCA gene mutation.

The first targeted therapy for a type of advanced, genetically based breast cancer is now available for United States women after the Food and Drug Administration (FDA) expanded the indications for an existing cancer agent called Lynparza.

The drug is among a class called poly ADP-ribose polymerase, or PARP, inhibitors, which are created to block an enzyme involved in repairing damaged DNA.

Industry experts further cite that the approval of such new improved options for patients with BRCA-caused cancer, will have a major impact on the growth trends of breast cancer therapeutics market and would encourage further investments in drug discovery. People who took the drug had an average 7 months of progression-free survival, compared to 4.2 months among people who were given only chemotherapy.

Lynparza also triggered a response in more patients than chemo as 52 percent responded to the treatment, compared to only 23 percent in the chemotherapy group.




"AstraZeneca and Merck Sharp and Dohme have received U.S. regulatory approval for Lynparza as a treatment for germline BRCA-mutated metastatic breast cancer".

This is the third indication approved for Lynparza in the U.S., where it has been used to treat almost 4,000 advanced ovarian cancer patients. According to the FDA's statement, approximately 5 to 10 percent of patients with any type of breast cancer have a genetic anomaly in their BRCA genes.

Researchers published their phase 3 trial findings in the New England Journal of Medicine.

While there is now no cure for metastatic breast cancer, todays approval offers a new, targeted option that may help to delay disease progression for these patients, Dr. Susan M. Domchek at the University of Pennsylvanias Abramson Cancer Center said in a statement. Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.

One of the next frontiers is combination treatment, where the three competitors are being investigated in a range of different tumour types and settings.


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