Cancer Drugs with Breakthrough Status – on a Fast Track, But is it Fast Enough?


FDA Breakthrough StatusThe advent of the FDA Safety and Innovation Act of 2012 has led to an onslaught of new cancer treatments waiting to be approved. Now that the FDA can legally create a new status, known as a “breakthrough” designation, patients with life-threatening diseases such as cancer can obtain their medications faster and more efficiently. However, the advantage of fast-tracking a new drug is still not quite enough to meet the demands of an ever growing aging and disease-burdened population. While research and development of new drugs to treat life threatening diseases has ballooned, there is still a growing demand for newer and efficacious treatments to help those patients who need a lifesaving miracle. Scientists, physicians, pharmaceutical companies, patients and their families are all hopeful that as the new drug filings are presented to the FDA they will continue to hold the highest standards and be expeditious in their approvals.

The following drugs have been declared as having “breakthrough” status with the FDA as cancer treatments, and their respective manufacturers hope to market their medication in as short of a time period as possible:

ibrutinibIbrutinib CAS# 936563-96-1 – This experimental drug used to treat chronic lymphocytic leukemia is different from the usual chemotherapy treatments in that it pointedly targets specific processes, and prevents tumor proliferation. After binding to B-cells Ibrutinib works efficaciously by not only stopping tumor growth and division, but also by not affecting the patients’ T-cell count. With many patients suffering from aggressive forms of chronic lymphocytic leukemia, known to be the result of genetic mutations, options for successful treatment with a medication like Ibrutinib are literally lifesaving.

Lambrolizumab CAS# 1374853-91-4 – Merck announced a breakthrough therapy designation from the FDA in late April 2013 for this formidable drug designed to treat patients with advanced stages of melanoma. Lambrolizumab is unique in that it is an investigational antibody therapy which targets the programmed death receptor, or PD-1. Melanoma is a ravaging disease, accounting for over 80 percent of all deaths from skin cancer.

Daratumumab CAS# 945721-28-8 – On May 2, 2013 researchers from Genmab announced a breakthrough status for Daratumumab. This powerful treatment is especially effective for patients with refractory or advanced multiple myeloma. Targeted at patients with metastatic disease, patients who receive Daratumumab should have been previously administered three or more types of therapy without success, including both an immunomodulatory agent and a proteasome inhibitor.

LGM Pharma provides Ibrutinib, Lambrolizumab and Daratumumab for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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