In groundbreaking move, FDA approves Myovant's relugolix as the first once-a-day pill for advanced prostate cancer
Myovant Sciences $MYOV won’t be getting coal in their stocking this Christmas.
The Swiss biotech, formerly part of the Vivek Ramaswamy family of Vants, won FDA approval of its relugolix drug on Friday afternoon for the treatment of advanced prostate cancer. It’s the first oral hormone therapy approved for the indication, regulators said, and the drug will be marketed as Orgovyx. PDUFA action had been scheduled for Dec. 20.
Orgovyx will be priced at $2,300 per month, CEO Lynn Seely told Endpoints News on Monday.
Investors briefly cheered the green light, sending shares up roughly 7% immediately after the approval. But Myovant’s stock slid back to its previous levels and sat down about 5% later Friday.
With the risk immunosuppressed cancer patients face in the wake of the Covid-19 pandemic, the agency highlighted patients’ ability to take Orgovyx at home as a benefit for the drug. The standard of care in this field, AbbVie’s Lupron, needs to be injected once every three months, and other treatments typically are placed as implants under the skin.
Orgovyx also “may eliminate some patients’ need to visit the clinic for treatments that require administration by a healthcare provider,” FDA oncology chief Richard Pazdur said in a statement.
Seely said, however, that she believed the benefits can help the drug stand out on its own, with or without a pandemic.
“We know from our research that the majority of men prefer an oral treatment to an injection,” Seely said. “Now, all that being said, with the Covid-19 pandemic, there is a recommendation from the National Comprehensive Cancer Network for patients with cancer to avoid hospitals and clinics as much as possible. It’s, we believe, one of the reasons we were granted priority review by the FDA.”
Friday’s approval came on the basis of a Phase III study from back in November 2019, which pitted Orgovyx head-to-head with Lupron in men with prostate cancer. The idea behind the program is centered around testosterone production — because prostate cancer is fueled by the hormone, Myovant had sought to cut testosterone levels to a point that would qualify as medical castration.
The primary endpoint in that study showed 96.7% of men treated with Orgovyx achieved sustained testosterone suppression over 48 weeks, compared to 88.8% on Lupron. Regulators had set a benchmark of at least 90% clearance, CEO Lynn Seely told Endpoints News at the time.
Approval came despite Orgovyx whiffing badly on a key secondary endpoint when further data came out in September, as the drug fared numerically worse in castration resistance-free survival after 48 weeks than Lupron. In the subgroup of men with metastatic prostate cancer, 74% of those treated with Orgovyx were alive and castration-resistance free through 48 weeks, compared to 75% on Lupron.
The p-value of the endpoint was p=0.84, and Myovant shares were crushed by 25% at the time.
Notably, however, Orgovyx managed to beat out Lupron on major cardiovascular events, showing a 2.9% rate against the AbbVie drug’s 6.2% rate. The superiority in these safety events is a big reason why SVB Leerink analyst Ami Fadia says Myovant can position Orgovyx as a more appealing option to physicians.
As a gonadotropin-releasing hormone (GnRH) antagonist, Orgovyx works by blocking the receptor, an approach that contrasts with Lupron. The AbbVie drug desensitizes the receptor by hitting it repeatedly.
Prostate cancer is one of three indications in which Myovant has prepped approval packages for both the FDA and EMA. The other fields are uterine fibroids, with a PDUFA date set for next June 1, and endometriosis, where the company is planning NDA and European submissions for the drug later in 2021. Orgovyx uses the same pathway to lower testosterone in men as it does to lower estrogen and progesterone in women.
AbbVie isn’t content to let bygones be bygones, however, as it’s been prepping a Lupron successor for some time. Back in May, the FDA approved the company’s elagolix in combination with two hormone drugs, estradiol and norethindrone acetate, for uterine fibroids. Myovant is looking at using Orgovyx in combination with ABT in that field, and saw 50% or more reduction in blood loss in two Phase III studies, similar to AbbVie’s approach.
Myovant company is also expected to approach European regulators for approval in prostate cancer in the first half of next year.