FDA Grants Breakthrough Therapy designation to Drug Duo Fighting Endometrial Cancer


The Food and Drug Administration has decided to award Breakthrough Therapy status to a combination of drugs designed to treat advanced and/or metastatic non–microsatellite instability-high (MSI-H)/proficient mismatch repair endometrial carcinoma.

Eisai and Merck, the two pharmaceutical companies behind this joint venture, announced that their collaboration for Lenvima (lenvatinib) and Keytruda (pembrolizumab) has just received this designation. This is the second time in the last six months they received this classification which awards increased development and review of drugs showing substantial promise in treating serious conditions.

In the press release, Dr. Takashi Owa states that: “We designed Study 111 to learn as much as we could about the LENVIMA/KEYTRUDA combination as efficiently as possible, driven by a sense of urgency to bring forward a potential new treatment option for patients in need”.

The aforementioned study, conducted on 53 patients with selected solid tumors that had gone through at least one round of systemic therapy, involved administering the combination of drugs over a 24 week period, at three-week intervals.

In the end, the median rate of progression-free survival was 7.4 months.  Nineteen patients had stable disease and in only five cases the disease progressed.

There are about 63 thousand cases of endometrial carcinoma each year and about one in six patients die as a result. If caught in the initial stages, the five-year survival rate is about 88%, though this drops significantly, to only 15% for those diagnosed in the latter stages.

Roy Baynes, M.D., Ph.D., senior vice president and head of global clinical development, chief medical officer for Merck Research Laboratories expressed his commitment for the collaboration: “We will continue to work closely with Eisai to build on the robust data for the Lenvima/Keytruda combination in advanced endometrial carcinoma in an effort to offer a new option for these patients and potentially help address a critical unmet need.

As with most drugs, there are some side effects from the treatment. These can include hypertension, fatigue, headaches, nausea.

For more information about LENVIMA see link.

Medication guide for KEYTRUDA here.