AstraZeneca
AZN
and partner
Merck
MRK
announced that the FDA has approved their PARP inhibitor Lynparza to treat BRCA mutated (BRCAm) early breast cancer.
Lynparza is now approved as an adjuvant treatment for patients with BRCAm HER2-negative high-risk early breast cancer previously treated with chemotherapy either before or after surgery.
The approval for the expanded indication was based on data from the OlympiA phase III study. In the study, treatment with Lynparza reduced the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo, thereby demonstrating statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS). New data from the OlympiA study also showed that Lynparza reduced the risk of death by 32% versus placebo, thereby demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) which was the study’s key secondary endpoint.
Lynparza is already approved for the treatment of germline BRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial.
An estimated 2.3 million patients were diagnosed with breast cancer in 2020. Around 91% of all breast cancer patients are diagnosed at an early stage of the disease. For patients with early breast cancer who are at higher risk at diagnosis, the risk of cancer returning can be high, which demands new treatment options. The OlympiA study showed that treatment with Lynparza reduces the risk of recurrence and improves survival in such women with high-risk early breast cancer disease
With the approval for the early breast cancer indication, Lynparza can cater to a significantly expanded patient population.
This year so far, AstraZeneca’s shares have risen 5.2% while Merck’s shares are up 2.1%. The
industry
has witnessed a decrease of 2.3% in the said time frame.
Image Source: Zacks Investment Research
At present, Lynparza, is approved for four cancer types, ovarian, breast, prostate and pancreatic for various patient populations. It has been used to treat over 40,000 patients worldwide. Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well as some other cancer types.
Lynparza is being jointly developed and commercialized by AstraZeneca and Merck. The drug generated product sales of $2.35 for AstraZeneca in 2021, and alliance revenues of $989 million for Merck.
Other PARP inhibitors available in the market include
Glaxo
’s
GSK
Zejula and
Clovis Oncology
’s
CLVS
Rubraca and Pfizer’s Talzenna.
While Glaxo’s Zejula is approved only for an ovarian cancer indication, Clovis’ Rubraca is approved for BRCA mutated ovarian cancer and metastatic castrate-resistant prostate cancer indications.
A broad development program on Rubraca is currently underway across a variety of solid tumors. Clovis is looking to expand Rubraca’s label into additional cancer types like breast and gastroesophageal cancers, among others.
On the other hand, Glaxo’s Zejula is being evaluated for additional ovarian cancer stages as well as for non-small cell lung cancer and breast cancer.
Both Merck and AstraZeneca have a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
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