ust as I had updated my new drug tally last week, another one progresses. No complaints, mind you. In fact, it’s wonderful news.
Here are the updated totals: 4 new drugs in the past two years including Jevtana (cabazitaxel), Xgeva (denosumab), Provenge and Zytiga (abiraterone). Another, enzalutimide (MDV3100) is pending approval for the FDA and currently available to patients under an expanded access program. A promising new radiotherapy, Alpharadin (radium-223 chloride) is working its way through the approvals process with a Fast-Track designation from the U.S. Food and Drug Administration (FDA).
Now today, Tokai Pharmaceuticals Inc., a biopharmaceutical company based in Cambridge, Massachusetts, said in a press release that the Food and Drug Administration has granted Fast-Track status for its lead drug candidate, a potential treatment of metastatic treatment-resistant (otherwise known as castration-resistant) prostate cancer.
As reported by Chris Reidy, of the Boston Globe, “Fast-track designation is reserved for the review of experimental drugs that treat serious or life-threatening conditions or address unmet medical needs. In general, regulators spend about 10 months reviewing a drug candidate before issuing a decision. Getting fast-track status means that Tokai could get a decision in six months on whether or not the FDA will approve the drug.”
Tokai’s drug is galeterone, or TOK-001. It aims to treat castration-resistant prostate cancer, or CRPC, an advanced, difficult-to-treat form of prostate cancer that occurs when the disease progresses despite the use of androgen deprivation therapy.
Despite recent progress in prostate cancer treatment, CRPC often becomes resistant to androgen deprivation therapy, and galeterone’s unique triple mechanism of action may offer an important therapeutic advance, said Martin D. Williams, Tokai’s presiden t and chief executive. “We are very encouraged by the recent positive results from our ARMOR1 clinical study, and we look forward to advancing galeterone into Phase 2 development in patients with CRPC later this year.”
Of these drugs that work on the androgen receptor (AR), Zytiga, TOK-001, and Enzalutimide, they target varying and multiple mechanisms in signalling pathways for disease progression. So, not only do we have more weapons in our arsenal for advanced disease, we will also be able to study which patients and varieties of prostate cancer respond best to specific drugs or combinations of these new therapies and move closer to patient-specific treatments.
Let the numbers roll… I am up for constantly having to revise them.