On May 8, Merck (MRK) and AstraZeneca (AZN) managed to secure approval from the European Medicines Agency for Lynparza as maintenance therapy in platinum-sensitive epithelial ovarian cancer indication, irrespective of their BRCA status. The approval also extends the use of the drug in platinum-sensitive, high grade, and relapsed primary peritoneal cancer indication in the maintenance setting, irrespective of the patients’ BRCA mutation status.
On July 2, Lynparza secured approval from Japan’s Pharmaceuticals and Medical Devices Agency for patients suffering from BRCA-mutated HER2- metastatic breast cancer, where the tumor was unresectable or recurrent, and the patient had already been treated with chemotherapy.
Merck and AstraZeneca are also evaluating Lynparza’s potential in combination with standard of care and abiraterone in previously treated metastatic castrate-resistant prostate cancer patients.
The above diagram shows the key anticipated milestones for Merck’s oncology research program until the end of 2019.
Lenvima’s growth trends
Merck has started promoting Eisai’s Lenvima in the United States in RCC (renal cell carcinoma) and DTC (differentiated thyroid cancer) indications since June. The companies are also preparing to launch the drug in other international markets in Europe, like Germany and the United Kingdom, and in the Asia-Pacific region.
Merck and Eisai are also awaiting FDA approval for the drug in HCC (hepatocellular carcinoma) indication by the Prescription Drug User Fee Act date of August 24. On March 23, the drug secured approval in Japan in first-line unresectable HCC indication, which is the first front-line treatment for HCC in the past ten years. According to Eisai’s internal estimates, Lenvima has helped almost 2,800 first-line HCC patients in Japan in the four months since it secured regulatory approval.
In addition to Lenvima monotherapy, the drug is also being evaluated in combination with Keytruda in front-line RCC indication and second-line endometrial carcinoma indication in Phase 3 trials. In combination with Keytruda, Lenvima is also being studied in Phase ½ trials in endometrial carcinoma, NSCLC, RCC, head and neck squamous cell carcinoma, melanoma, and urothelial carcinoma indications. Finally, this combination regimen is also being evaluated in HCC indication in Phase 1/2b trial.