The FDA has approved darolutamide (Nubeqa – Bayer), an androgen receptor inhibitor, for oral treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is the third androgen receptor inhibitor to be approved for this indication; apalutamide (Erleada) and enzalutamide (Xtandi), which are also approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC), were approved earlier.

The androgen receptor inhibitor darolutamide (Nubeqa – Bayer) has been approved by the FDA for use in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer (mHSPC). The drug was previously approved for treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC).

The oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx – Myovant Sciences/Pfizer) has been approved by the FDA for treatment of advanced prostate cancer in adults. It is the first oral GnRH receptor antagonist to become available in the US; degarelix (Firmagon), an injectable GnRH receptor antagonist, has been available since 2008 for the same indication.

Dehydroepiandrosterone (DHEA) is an adrenal androgen now being marketed as a "food supplement"in health food stores. DHEA is not approved for any indication by the US Food and Drug Administration (FDA).

Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.

The FDA has approved enzalutamide (en za loo’ ta mide; Xtandi – Astellas/Medivation) for oral treatment of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and generics). It is the second oral drug approved for this indication; abiraterone acetate (Zytiga), which is also approved for first-line use, was the first. Cabazitaxel (Jevtana), which is given parenterally, has a similar indication.

Flutamide (Eulexin - Schering), an oral antiandrogen, is now available in the USA for treatment of metastatic prostate cancer. Flutamide is recommended by the manufacturer only for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron - Medical Letter, 27:71, 1985).

Bicalutamide (Casodex - Zeneca), an oral nonsteroidal antiandrogen similar to flutamide (Eulexin - Medical Letter, 31:72, 1989), is now available in the USA for treat-ment of advanced prostate cancer. The drug is recommended by the manufacturer for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron; Lupron Depot) or goserelin (Zoladex -Medical Letter, 32:102, 1990).

Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet...

In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for prophylaxis and the C1 esterase inhibitor Berinert and the kallikrein inhibitor ecallantide (Kalbitor) for treatment of acute attacks.