Avzivi Biosimilar for Avastin Approved

The U.S. Food and Drug Administration (FDA) approved Avzivi^® (bevacizumab-tnjn – Bio-Thera Solutions) injection, a new biosimilar for Genentech’s Avastin^®, on Dec. 6, 2023. A vascular endothelial growth factor (VEGF) inhibitor, it typically is used in combination with chemotherapy (chemo) or other drugs to treat some cervical cancer, colorectal cancer (CRC), glioblastoma, non-small cell lung cancer (NSCLC), ovarian and related cancers and renal cell carcinoma (RCC). Given by intravenous (IV) infusions once every two weeks or every three weeks, doses vary according to the cancer being treated. Sanofi will market Avzivi in the United States. Pricing and launch plans have not been announced. Four previously FDA-approved biosimilars for Avastin – Alymsys^® (bevacizumab-maly – Amneal Pharmaceuticals), Mvasi (bevacizumab-awwb – Amgen), Vegzelma (bevacizumab-adcd – Celltrion) and Zirabev^® (bevacizumab-bvzr – Pfizer Oncology) – are already sold in the United States. Check here for Avzivi’s full prescribing information.

New Indications for Jaypirca

Eli Lilly and Company’s Jaypirca^® (pirtobrutinib) tablets got Accelerated Approval from the FDA on Dec. 1, 2023, for two new indications. Originally given the FDA’s Accelerated Approval in January 2023, to treat adults who have relapsed or refractory mantle cell lymphoma (r/r MCL), Bruton’s tyrosine kinase (BTK) inhibitor now also is indicated to treat r/r chronic lymphocytic lymphoma (CLL) and r/r small lymphocytic lymphoma (SLL) in adults. Additional positive clinical study results will be needed before final approval is granted for any of its uses. For the new indications, patients must have been treated previously with two or more other therapies, which include another BTK inhibitor, such as Imbruvica^® (ibrutinib), and a B-cell lymphoma 2 (BCL-2) inhibitor, such as Venclexta^® (venetoclax). Because Jaypirca blocks BTK in different ways than other drugs in the class, it can be used after another BTK inhibitor has stopped working. For all indications, its recommended dose is 200mg once every day. Patients taking it should be alert for heart rhythm changes, infections, and unusual bleeding. Complete blood counts (CBCs) should be done periodically during treatment because using Jaypirca may decrease the formation of red and/or white blood cells. Some patients may develop secondary cancers, particularly skin cancers. Since unborn babies may be injured, women who may become pregnant during treatment should use reliable forms of contraception until at least one month after therapy ends. For its revised prescribing information, look here.

Wilate Indication Extended

The indications for Wilate^® (von Willebrand factor/coagulation factor VIII complex [human] – Octapharma) injection have been expanded. On Dec. 1, 2023, the FDA approved routine prophylaxis to lower the risk of acute bleeds for all patients who have von Willebrand disease (VWD) who are at least six years old. Previously, preventive use was limited to patients who have severe forms of the condition. According to the Centers for Disease Control and Prevention (CDC), VWD is believed to affect about 3.2 million Americans. VWD is an inherited blood clotting disorder that is about twice as common among females as males. Approximately 15% of patients have serious or severe forms of the condition that cause frequent bruising and episodes of intense and/or prolonged bleeding spontaneously or after small injuries. Wilate has additional approvals for treating bleeds and controlling bleeds associated with surgical procedures for all patients aged six and older who have VWD. It also is indicated to decrease the risk of bleeds and to treat acute episodes for teens and adults who have hemophilia A. To manage acute episodes, weight-based doses are administered as intravenous (IV) infusions at amounts that depend on the severity of the bleeding. To prevent bleeds, the recommended dose of Wilate is 20IU/kg to 40IU/kg two or three times each week. Here is its updated prescribing information.

First Generic Approved for Condylox Gel

Podofilox gel, 0.5% was FDA approved on Dec. 5, 2023, as the first generic for Allergan’s Condylox Gel, 0.5%. The topical treatment is used to treat external genital and perianal warts, which result from infection with some types of human papillomavirus (HPV). Typical symptoms include bleeding, increased mucus, and itching in the affected area. To treat the warts, the gel is applied to them two times a day for only the first three days of each week until the warts have disappeared. However, Podofilox gel should not be used for more than four weeks. It should be used only on the external genital and perianal area, not inside the genitals or anus. Individuals using it should wash their hands carefully after applying the gel and be sure not to get any of it in their eyes. Because the gel is flammable, it should not be used or stored near any open fire source, including candles. Under the FDA’s Competitive Generic Therapy (CGT) program, the manufacturer, Hyloris Pharmaceuticals, and its partner, Padagis, which will market podofilox gel in the U.S., have 180 days of marketing exclusivity. They plan a launch later in December, but pricing is not yet available. IQVIA estimated the U.S. sales of Condylox Gel at around $9 million for 2022.