Four Recent FDA Drug Approvals: Myovant, Integrum, AstraZeneca and Ridgeback

FDA Approval_Compressed

The U.S. Food and Drug Administration (FDA) has approved several drugs and medical devices in the last week. Here’s a look.

Myovant’s Orgovyx for Advanced Prostate Cancer

On December 18, the FDA approved Myovant Sciences’ Orgovyx (relugolix) for treatment of adults with advanced prostate cancer. The drug was granted Priority Review and is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. The approval was based on data from the Phase III HERO trial.

“I am enormously pleased by the approval of Orgovyx and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy,” said Neal Shore, medical director of the Carolina Urologic Research Center and HERO program steering committee member. “For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone, with a safety analysis showing a lower incidence of major adverse cardiovascular events compared to leuprolide injections, the current standard of care, as evaluated in the Phase III HERO study.”

Integrum’s OPRA Implant System for Above-the-Knee Amputations

The FDA also approved on December 17, Sweden-based Integrum AB’s OPRA Implant System, a class III medical device. It is an American Premarket Approval process. A typical leg prosthesis uses a specially-fitted, cup-like shell (socket) that fits over the remaining part of the patient’s leg. But not all patients have a long enough residual limb to properly fit a socket prosthesis or may have scarring, pain or other conditions that prevent it. The OPRA Implant System is surgically anchored and integrated into the patient’s remaining thigh bone.

“Today’s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses,” said Capt. Raquel Peat, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices. “Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities.”

AstraZeneca’s Tagrisso for EGFRm Non-Small Cell Lung Cancer

On December 21, the FDA approved AstraZenecas Tagrisso (Osimertinib) for adjuvant treatment of adults with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent. The drug is indicated for EGFRm patients whose tumors have exon 19 deletion or exon 21 L858R mutations. The approval was made under the agency’s Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process via FDA’s Project Orbis.

“For the first time, a targeted, biomarker-driven treatment option is available to patients in the US with early-stage EGFR-mutated lung cancer,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca. “This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease. We remain committed to treating cancer patients earlier, when they may still have a chance of being cured.”

Ridgeback Therapeutics’ Ebanga Antibody Treatment for Ebola

On December 21, the FDA approved Ridgeback Therapeutics’ Ebanga (ansuvimab-zykl) for treatment of Zaire ebolavirus infection in adults and children. Ebanga is a human monoclonal antibody that blocks binding of the Ebolavirus to the cell receptor, preventing its entry into the cell. Zaire ebolavirus is one of four Ebolavirus species that can cause the potentially fatal disease. The therapy was evaluated in the PALM trial during the Ebola outbreak in the Democratic Republic of the Congo (DRC) in 2018-2019. The trial was led by the U.S. National Institutes of Health and the DRC’s Institut National de Recherche Biomedicale.

In the PALM Trial, Ebanga was evaluated in 174 participants, 120 adults and 54 children, with confirmed Ebolavirus infection. They received an IV of a single 50 mg/kg infusion; 168 participants, 135 adults and 33 children, received an investigational control. The primary efficacy endpoint was 28-day mortality. Of the 174 patients receiving Ebanga, 35.1% died after 28 days, compared to 49.4% of the 168 patients who received a control.

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