FDA Approves Last Specialty Tx of 2020 – Orgovyx

prostate Tx

The FDA approved the last specialty therapy for 2020 just in time for Christmas. The new oral drug, Orgovyx from four-year-old Myovant Sciences, is indicated for advanced prostate cancer.

The American Cancer Society estimates more than 190,000 cases of prostate cancer in the U.S. will have been diagnosed in 2020. Current treatment options for advanced prostate cancer includes androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are infused or placed as small implants under the skin. Orgovyx is a first-in-class, non-infused option for these patients. Analysts believe that patient concerns associated with COVID-19 exposure will drive Oncologists to prescribe an oral regimen vs. hospital or clinic infusions/implants.

The company plans to launch Orgovyx , a gonadotropin-releasing hormone antagonist, in January.

Orgovyx carries a list price of $2,313 per 30 tablet supply.
The approval of Orgovyx was another lump of coal in the Christmas stocking of specialty pharmacies nationally. Only a few select SPs will enjoy yet one additional limited distribution product this new year.

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

Dec 21, 2020 — 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 Orgovyx in January.

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.

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.

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.”

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.


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