AstraZeneca’s drug to cure early breast cancer, Lynparza was approved in the US.
Lynparza is the first and only approved drug to aid patients with BRCA-mutated HER2-negative high-risk early breast cancer and have already used chemotherapy.
Lynparza was created by AstraZeneca and Merck’s (MSD) olaparib drug. The drug gained approval of the FDA after the results from OlympiA Phase III trial was presented at the 2021 American Society of Clinical Oncology Annual Meeting.
Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial said, “today’s approval of olaparib is great news for patients with a specific inherited form of breast cancer.”
“OlympiA has shown that identifying a BRCA1/2 mutation in women with high risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients.”
The trial results showed that Lynparza has statistical improvements in the treatment of early breast cancer with improvements in invasive disease-free survival, reduced risk of invasive breast cancer recurrences, second cancers or death by 42% as opposed to a placebo.
The drug also showed improvements in the stats for overall survival and reduced the risk of death by 32% versus placebo.
“Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients’ lives versus placebo,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.
Breast Cancer Treatment
Breast cancer is a biologically diverse tumour where an array of factors play a role in their unique development.
BRCA1 and BRCA2 are genes which make protein and repair DNA damage. If the BRCA genes changed in any way, the protein production is altered resulting in DNA damage remaining and cells becoming unstable.
Around 2.3m patients were diagnosed with breast cancer in 2020 with 91% diagnosed at an early stage in the US and 5-10% found the BRCA mutations.
More about Lynparza
Lynparza (olaparib) is a PARP inhibitor and a pioneer in the treatment to block DNA damage response in cells or tumours harbouring a deficiency in homologous recombination repair, for patients with mutations in BRCA1 or BRCA2.
FDA approved diagnostic tests will select patients to be treated by Lynparza.
The approval of the drug begins in the US and extends to EU, Japan and many other countries with patients with the BRCA gene provided they’ve been treated with chemotherapy as suggested by OlympiAD Phase III trial.
Following the approval of Lynparza in the US, AstraZeneca will collect a ‘regulatory milestone payment’ of $175 million from MSD, which will be recorded as Collaboration Revenue in Q1 of 2022.