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FDA Updates for the Week of Feb. 26: Another Humira Biosimilar Approved, Rybrevant Receives Full Approval


FDA has expanded the indication for Biktarvy for those with resistant HIV, granted full approval to Rybrevant and approved Simlandi, the third interchangeable Humira biosimilar. The regulatory agency has also set action dates for sxatilimab in graft-versus-host disease, tislelizumab in stomach cancer and a second indication for Epkinly.

FDA Grants Full Approval to Rybrevant in Lung Cancer

The FDA has converted the accelerated approval of Rybrevant (amivantamab-vmjw) to full as the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Rybrevant is indicated to be used in combination with chemotherapy (carboplatin-pemetrexed) to treat patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Developed by Johnson & Johnson, Rybrevant is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity. It received accelerated approval by the FDA in May 2021.

The cost for Rybrevant intravenous solution is about $3,677 for a supply of 7 milliliters, according to Drugs.com.

The full approval is based on the results of the confirmatory phase 3 PAPILLON study. The study showed that Rybrevant plus chemotherapy resulted in a 61% reduction in the risk of disease progression or death compared with chemotherapy alone

FDA Approves Simlandi, Third Interchangeable Humira Biosimilar

The FDA has approved Simlandi (adalimumab-ryvk), which joins Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as interchangeable with AbbVie’s Humira’s (adalimumab), the reference brand-name product that has set all kinds of sales records, for some uses.

A total of nine Humira biosimilars are on the market in the United States, so Alvotechn's Simlandi will be the 10th when it launches in the second quarter. Pricing will be available at that time, according to a spokesperson.

Alvotech, which is headquartered and has manufacturing facilities has in Iceland, is a late comer to the U.S. Humira biosimilar market because the FDA identifying problems with its manufacturing processes, which lead to two complete response letters, which is an official FDA notification that tells a manufacturer that their application will not be approved in its current form.

FDA Expands Indication for Biktarvy for Those with Resistant HIV

The FDA has approved an expanded indication for Gilead’s Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets). It is now approved to treat people with HIV who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance.

Between 22% and 63% of people with HIV with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes have the M184V/I mutation.

Biktarvy is currently indicated as a treatment for people with HIV-1 infection in adults and pediatric patients weighing at least 14 kg. For the full year 2023, Biktarvy generated $11.9 billion in worldwide revenue, a 14% increase over 2022. Company officials said in a press release that this is a result of higher demand and higher average realized price.

The list price of Biktarvy is $3,981 per month. Patients with commercial insurance may pay as little as $0 per month with the Gilead Advancing Access copay coupon with a limit of $9,600 annually.

FDA Grants Priority Review for Second Epkinly Indication

The FDA has granted priority review review to the supplemental biologics license application (sBLA) for Epkinly (epcoritamab-bysp), a subcutaneously administered T-cell engaging bispecific antibody to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of therapy. A priority review shortens the agency’s review time to six months; the target date is in August 2024.

Developed by AbbVie and Genmab, Epkinly was approved in May 2023 as a third-line therapy to treat patients with diffuse large B-cell lymphoma (DLBCL) treatment. Epkinly that targets CD3 on the surface of T cells and CD20 on the surface of B cells. Epkinly is a monthly therapy with a cost of $37,500 per month.

The current maximum benefit is $25,000 per year. In 2023, Epkinly generated $31 million in worldwide revenue for AbbVie. Under the agreement with AbbVie, Genmab receives royalties of between 22% and 26% on net sales outside the United States and Japan. Genmab and AbbVie evenly split product sales in other territories.

FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease

The FDA has accepted for priority review Incyte’s biologics license application (BLA) for axatilimab to treat patients with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. The Prescription Drug User Fee Act (PDUFA) date is Aug. 28, 2024.

Graft-versus-host disease is a complication of stem cell transplants, where the body’s immune system attacks the new cells. Acute graft-versus-host can occur in about half of patients receiving hematopoietic stem cell transplantation from matched donors. The occurrence can be higher in unmatched donors

Axatilimab, developed by Incyte and Syndax Pharmaceuticals, is a monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein.

The BLA is supported by data from the AGAVE-201 trial, which showed that treatment with axatilimab resulted in clinically meaningful results and was generally well-tolerated, with a safety profile that was manageable and consistent with the mechanism of action of CSF-1R inhibition.

FDA Sets Review Date for Tislelizumab in Stomach Cancer

The FDA has accepted BeiGene’s biologics license application (BLA) for Tevimbra (tislelizumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, to treat patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The FDA’s action date on the BLA is expected in December 2024.

Tevimbra is humanized IgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

The filing is based on results from the global RATIONALE-305 trial, which met its primary endpoint of overall survival of 15.0 months for patients treated with Tevimbra in combination with investigator’s choice of chemotherapy compared with 12.9 months for patients treated with placebo plus chemotherapy. Tevimbra demonstrated a 20% reduction in the risk of death.

Data were presented at the European Society for Medical Oncology (ESMO) Congress 2023.

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