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FDA Updates for the Week of July 31, 2023


FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.

FDA Approves Lonsurf Combination for Metastatic Colorectal Cancer.

The FDA has approved Lonsurf (trifluridine and tipiracil) as a single agent or in combination with Avastin (bevacizumab) to treat adult patients with metastatic colorectal cancer (mCRC). It is indicated for patients who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, or an anti-EGFR therapy.

Developed by Taiho Oncology, Lonsurf is also approved to treat adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma. The recommended dosage for Lonsurf is 35 mg/m2 orally twice daily on days 1 through 5 and days 8 through 12 of each 28-day cycle.

The most commonly ordered bottle size is 60 tablets of 20 mg, which has a wholesale acquisition cost of $15,935.23, according to a spokesperson for Taiho Oncology. Sixty tablets of 15 mg has a wholesale acquisition cost of $11,951.44. Biosimilars are available for Avastin, and the spokesperson said the Medicare Allowable for the combination of Lonsurf/bevacizumab ranges from $18,754.33 to $23,293.20 per cycle.

FDA Approves Jemperli as Frontline Treatment for Advanced Endometrial Cancer

The FDA has approved GSK’s supplemental biologics license application (sBLA) for Jemperli (dostarlimab-gxly) in frontline treatment for patients with advanced or recurrent endometrial cancer, making it the first immune-oncology treatment for this patient population. Jemperli is indicated for patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) in combination with carboplatin and paclitaxel.

Jemperli is already approved in the United States as monotherapy in adult patients with dMMR recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen.

Endometrial cancer is the most common gynecologic cancer globally, with about 417,000 new cases reported each year worldwide. About 15% to 20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis. Patients with advanced disease typically have poor outcomes.

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody. The price of is about $11,712 per 500 mg/10 mL vial, which is initially given once every three weeks for four doses, according to Drugs.com. GSK offers co-pay assistance of up of $26,000 for patients with commercial insurance.

FDA Rejects BLA for Therapy to Treat Rare Skin Cancer

The FDA has issued a complete response letter to Citius Pharmaceuticals for its biologics license application (BLA) seeking approval for Lymphir (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein to treat patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).

The agency is asking Citius to do enhanced product testing and include additional controls. Company officials said in a press release there were no concerns relating to the safety and efficacy or with the prescribing information.

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions.

Lymphir (previously called I/Ontak) is a recombinant fusion protein that combines interleukin-2 (IL-2) receptors with diphtheria toxin fragments. It binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis.

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