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FDA Updates for the Week of Dec. 19, 2022


In a busy week for FDA approvals, the agency cleared several first in class therapies: a treatment for HIV-1 and for follicular lymphoma. Other approvals include: Tymlos for osteoporosis in men; Vraylar for major depressive disorder; Cytalux to identify lung cancer during surgery. In COVID-19 news, the agency approved Actemra for hospitalized patients. The FDA has also accepted a sBLA for Padcev, Keytruda combo for urothelial cancer.

FDA approves first bispecific antibody for follicular lymphoma.

The FDA has granted accelerated approval of Genentech’s Lunsumio (mosunetuzumab-axgb) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). It is indicated for patients after two or more lines of systemic therapy.

Follicular lymphoma is the most common slow-growing form of non-Hodgkin’s lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse.

Lunsumio is an off-the shelf bispecific antibody and represents a new class cancer immunotherapy. It targets CD20 on the surface of B cells and CD3 on the surface of T cells. This redirects a patient’s existing T cells to engage and eliminate target B cells.

Lunsumio will be available in the United States in the coming weeks.

FDA approves first-in-class HIV-1 treatment.

The FDA cleared Gilead Sciences’ Sunlenca (lenacapavir), in combination with other antiretrovirals, to treat HIV-1 infection in heavily treated adults with multi-drug resistant (MDR) HIV-1 infection. The twice-yearly treatment is for patients whose HIV is not adequately controlled by their current treatment regimen, Gilead said in a news release. Sunlenca has a multi-stage mechanism of action distinguishable from other currently approved classes of antiviral agents and no known cross resistance exhibited in vitro to other existing drug classes. Sunlenca is the first of a new class of drugs called capsid inhibitors. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle.

The anticipated wholesale acquisition cost (WAC) for Sunlenca injection and tablets is $42,250 per year during the initial year of therapy, and then $39,000 annually for maintenance years. Gilead expects U.S. commercial supply to be available in January 2023.

FDA clears Tymlos for osteoporosis in men.

The FDA has approved Radius Health’s Tymlos (abaloparatide), a parathyroid hormone related peptide analog, to increase bone density in men with osteoporosis at high risk of fracture. It was approved in April 2017 for postmenopausal women with osteoporosis.

This approval is based on the phase 3 ATOM study, a 12-month multicenter study designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis. The primary efficacy endpoint was the percent change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months, which was 8.5% in the Tymlos compared with 1.2% in the placebo group. In the study, 228 men were enrolled.

FDA approves Vraylar for major depressive disorder.

The FDA has approved AbbVie’s Vraylar (cariprazine), an oral antipsychotic approved to treat schizophrenia and bipolar depression, for an additional indication: as an adjunctive therapy to antidepressants to treat adults with major depressive disorder. Vraylar is co-developed with Gedeon Richter.

Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant, AbbVie said in a news release.

FDA expands Cytalux approval to identify lung cancer.

The FDA has approved a new indication for On Target Laboratories’ Cytalux (pafolacianine) to identify lung cancer lesions in adult patients. The drug is a diagnostic agent that is administered by intravenous injection before surgery. FDA approved Cytalux in November 2021 for identifying ovarian cancer lesions.

The label expansion was based on data from the phase 3 ELUCIDATE trial that investigated the use of Cytalux in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer. Of the 110 patients who received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery, 24% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection.

FDA approves Actemra for hospitalized patients with COVID-19.

The FDA has approved Genentech’s Actemra (tocilizumab) intravenous to treat patients 18 years of age and older who are hospitalized with COVID-19. It is indicated for patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 and is recommended for use as a single 60-minute IV infusion.

The FDA approval for COVID-19 patients follows the FDA’s emergency use authorization (EUA) for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in June 2021. The use of Actemra to treat hospitalized patients ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group remains in place. Since the beginning of the pandemic, more than 1 million people hospitalized with COVID-19 have been treated with Actemra worldwide.

FDA accepts sBLA for Padcev, Keytruda combo for urothelial cancer.

The FDA has accepted for priority review the supplemental biologics license applications for (sBLAs) for Seagen and Astellas Pharma’s for metastatic urothelial cancer combination treatment Padcev (enfortumab vedotin-ejfv) and Merck’s Padcev (pembrolizumab). The new combo would be to treat patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy.

The respective applications are intended to expand both labels for Padcev and Keytruda. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date for each application of April 21, 2023.

The respective sBLAs are supported by efficacy and safety data from the phase 1b/2 EV-103 Cohort A trial (KEYNOTE-869), published in the Journal of Clinical Oncology, and data from the phase 1b/2 EV-103 Cohort K trial, which was presented in a late-breaking session at the 2022 European Society of Medical Oncology (ESMO) Congress. The Cohort K study found that that the combination provides a durable option for patients whose disease may not be suitable for treatment with a cisplatin-based chemotherapy. Results demonstrated a 64.5% confirmed objective response rate by blinded independent central review, the primary endpoint of Cohort K. Median overall survival of patients treated with the combination was 22.3 months. Among patients treated with enfortumab vedotin, median progression free survival was 8.0 months, and median overall survival was 21.7 months.

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