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Erleada® (apalutamide) FDA approved: non-met Castration Resistant Prostate Cancer

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Old 02-16-2018, 04:16 PM   #1
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Talking Erleada® (apalutamide) FDA approved: non-met Castration Resistant Prostate Cancer

Two days ago (February 14) the prostate cancer community got a huge valentine from the US Food and Drug Administration (FDA): approval of the new drug Erleada®, with the technical name apalutamide, for non-metastatic castration resistant prostate cancer (nm-CRPC). In other words, this is for men who are no longer responding to androgen deprivation therapy (ADT, also known as hormonal therapy) but who have not yet developed detectable metastases. Up until now, there has not been a single drug approved for men in this situation.

Apalutamide is a kind of super antiandrogen. It is in a growing line of antiandrogens, starting with flutamide many years ago, then bicalutamide (Casodex®), and then enzalutamide (Xtandi®). While bicalutamide was a great improvement in convenience and power over flutamide, neither was very good at binding to and blocking the androgen receptor, which is like the fuel docking port for prostate cancer cells. That said, men in the nm-CRPC situation were often given 150 mg of bicalutamide along with regular ADT (often Lupron®, also Zoladex®, Viadur®, Trelstar®) and recently Firmagon® (degarelix), the latter being quite a bit more potent and in a slightly different class, an LHRH-antagonist rather than an LHRH-agonist.

Striking success in the recently published SPARTAN clinical trial (New England Journal of Medicine) led to accelerated review by the FDA.

Similar success for Xtandi® (enzalutamide) in a different trial (named PROSPER) of nmCRPC patients makes it likely that Xtandi® will also be approved for nmCRPC patients. (Xtandi® had been approved for metastatic CRPC after chemotherapy (docetaxel) on August 31, 2012, and on September 10, 2014, use of Xtandi® was extended to patients with metastatic CRPC who had not yet had chemo.)

For so many years there was almost no progress in adding drugs to the arsenal against prostate cancer. Docetaxel (chemo) was approved quite a while ago after a long period of no new approvals. In the past half dozen years or so the doors have opened, with approval of drugs including Zytiga® (abiraterone acetate), Xtandi®, Jevtana® (cabazitaxel), Firmagon® (degarelix), Xofigo® (radium 223 dichloride), Provenge® (sipuleucel-T), adding docetaxel early when ADT is started for high-risk prostate cancer, imaging agents, and some I've probably missed off the top of my head, as well as some drugs now in use "off-label" that barely missed approval (e.g., Yervoy® (ipilumumab).

It's heartening to see powerful new treatments becoming available under FDA approval for patients who have disease that is less advanced. Of course, these treatments can be used "off-label" where not approved, but sometimes there are prohibitive costs involved with no insurance coverage. (A number of my key drugs were prescribed off-label.)

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