Myovant scores FDA nod for Orgovyx, a first-in-class pill for advanced prostate cancer

Lynn Seely - Myovant
Myovant CEO Lynn Seely, M.D., said the company aims to make Orgovyx the standard of care in advanced prostate cancer. (Myovant)

Four years after its founding, Myovant Sciences has its first FDA approval in Orgovyx, a new oral treatment for advanced prostate cancer. A once-daily pill, the new medicine could become an attractive option for patients looking to avoid in-person injections during the ongoing COVID-19 pandemic.

With the nod, advanced prostate cancer patients “now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once a day,” Myovant CEO Lynn Seely, M.D., said in a statement.  The company plans to launch the newly approved gonadotropin-releasing hormone antagonist in January. Orgovyx carries a list price of $2,313 per bottle containing 30 pills.

Aside from scoring a new drug approval, the company has “successfully built our commercial capabilities" and aims to make the treatment the new standard of care, Seely said. 

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RELATED: Myovant's oral prostate cancer drug matches incumbent in phase 3 

In a phase 3 trial, investigators enrolled 934 men with advanced prostate cancer. Two-third received Myovant’s GnRH receptor antagonist, while the other third received depot injections of leuprolide, the standard of care for people undergoing androgen deprivation therapy. 

In those who received the Myovant drug, testosterone was suppressed to castrate levels in 96.7% of patients from week five to week 48, compared with 88.8% for leuprolide acetate injections. The FDA requires new drugs to achieve suppression levels in 90% of patients for approval.  

Plus, with patients taking precautions to avoid COVID-19 infections, the drug's at-home administration could be a deciding factor for patients and doctors. 

RELATED: Myovant's relugolix falls short in metastatic prostate cancer with FDA verdict looming 

In a note Friday, Evercore ISI analyst Josh Schimmer wrote to clients that the label "reads pretty clean" and that his team's communications with specialists revealed enthusiasm about the drug among prescribers. The analysts are confident the launch will "will drive shares meaningfully higher."

Aside from its initial approved use, Myovant is testing relugolix—the active ingredient in Orgovyx—as a combination tablet for uterine fibroids and endometriosis-associated pain.