Merck & Co.’s New Cancer Drug, Lambrolizumab, Joins Gang of Breakthrough Meds

Merck & Co. has announced that Lambrolizumab has recently been branded a breakthrough medication. This designation is a significant milestone for this therapy for advanced melanoma from pharmaceutical giant, Merck & Co. In effect, the US Food and Drug Administration (FDA) is pushing for the development of treatment options for a life-threatening condition by giving this drug said status. The FDA is officially expediting further review and development of Lambrolizumab.

Lambrolizumab joins three experimental drugs for cancer in the exclusive “breakthrough” category. The other three are:

(1) Spalbociclib or PD-0332991 by Pfizer (for metastatic breast cancer)
(2) LDK378 by Novartis (for ALK-positive lung cancer)
(3) Ibrutinib or PCI-32765(Johnson & Johnson’s) for many different types of leukemia and lymphoma

Promising treatment for advanced melanoma

80% of the mortality rate from skin cancer is attributed to advanced melanoma, and it accounts for 1-2% of all deaths due to cancer in the United States. Lambrolizumab, the latest Merck product to receive “breakthrough therapy” designation acts by inhibiting tumor growth by using the human body’s own immune system.

Lambrolizumab or MK-3475 is currently being evaluated for its treatment value as a drug for other forms of cancer. Merck & Co. is currently at mid-stage on the clinical trials. The drug company is determining its efficacy on the management of non-small cell lung cancer.

The results of earlier studies that involved 85 patients with metastatic melanoma (inoperable) were not completely announced. But the results of the open-label, phase 1 trial are very promising with the disappearance (or complete response) of cancer in eight of the patients included in the study. However, like most medications, there are side effects from taking this drug. These include diarrhea, joint pain, fatigue, itching, and fever.

Mechanism of action

Lambrolizumab is an FDA-approved immunotherapy drug. It is currently an “investigational antibody therapy” that targets PD-1 or Programmed Death Receptor, a surface protein. PD-1 is expressed on activated T-cells and acts as inhibitory signaling receptor. In effect, Lambrolizumab increases the ability of T-cells to act on tumor cells and kill them. Compared to similar drugs that act on PD-1or its ligand, Lambrolizumab has been shown to have positive effects on human subjects.

An important milestone

The FDA grants this designation to any experimental therapy once preliminary studies demonstrate that it has the potential to demonstrate improvements over therapies that already exist. The Senior Vice-President and head of Merck & Co’s oncology franchise Gary Gilliland said that the decision of the FDA is a milestone indeed and it comes at a time when they move forward to programs in the potential of Lambrolizumab for multiple cancer indications.

According to trial investigator and director of the Melanoma Center at the Angeles Clinic and Research Institute in Los Angeles Omid Hamid, this is a good time for patients such that this development signifies a return of hope. One of the benefits of a breakthrough designation is that patients would be encouraged to take part in clinical trials and contributes to their understanding that work is still being done.