FDA Approves DefenCath
The U. S. Food and Drug Administration (FDA) gave CorMedix approval for DefenCath® catheter lock solution (taurolidine/heparin) on Nov. 15, 2023. The combination of a new antimicrobial/antifungal drug with the widely used anticoagulant, heparin, is indicated to decrease the risk of catheter-related infections of the bloodstream for adult patients who are in kidney failure and who regularly undergo hemodialysis through a central venous catheter. It is the first drug of its type to be approved in the U.S. To keep pathogens from drifting into the body between dialysis treatments, DefenCath is injected into the closed-off lumen (the part of the catheter that remains outside the body) after each treatment and then removed before the next one. It is not injected into the patient. In a phase III clinical trial, patients receiving DefenCath had 71% fewer catheter-related infections than patients given heparin, alone. Its launch is planned for early 2024, but only a small number of patients in hospitals are expected to need it. DefenCath was approved under the FDA’s Fast-Track and Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) incentives. It also was designated as a Qualified Infectious Disease Product (QIDP), which gives it five additional years of exclusivity. Check here for its complete prescribing information.
Expanded Indication for Xtandi
Xtandi® (enzalutamide – Astellas Pharma/Pfizer) capsules and tablets received approval from the FDA on Nov. 16, 2023, for the treatment of nonmetastatic, castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). It can be used alone or along with a gonadotropin-releasing hormone (GnRH) analog such as leuprolide. An androgen receptor signaling blocker, Xtandi also is FDA-approved for treating patients who have castration-resistant prostate cancer (CRPC) or metastatic castration-sensitive prostate cancer (mCSPC). The recommended dose for all of its indications is 160mg (four capsules or tablets) taken all together once each day. The approval was granted under the FDA’s Fast Track, Priority Review, and Real-Time Oncology Review pathways. Revised prescribing information is here.
Keytruda Receives Extended Approval
The gastric cancer indication for Merck’s Keytruda® (pembrolizumab) was broadened by the FDA on Nov. 16, 2023. The inhibitor of programmed death receptor-1 (PD-1) now can be used, along with chemotherapy (chemo) that includes fluoropyrimidine and platinum, for the initial treatment of adults who have locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinomas that test negative for human epidermal growth factor receptor 2 (HER2-). Previously, it was indicated with chemo as first-line treatment of the same stomach cancers that are PD-1 positive. Keytruda also has FDA-approved indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers), rather than developing from a particular body tissue. In addition, it has numerous other indications — either alone or in combination with other cancer drugs — to treat some kidney cancers; some non-small cell lung cancers (NSCLC); some esophageal cancers; some head and neck cancers; and Merkel cell carcinoma (MCC), multiple myeloma and non-Hodgkin lymphoma (NHL). For most of its indications, including the newly extended one, the recommended dose is 200mg once every three weeks or 400mg once every six weeks administered as a 30-minute IV infusion. Here is its current prescribing information.
Levemir to be Discontinued
Novo Nordisk has announced that it will stop selling one of its long-acting insulins, Levemir® (insulin detemir), in the United States. The decision results from business considerations; safety issues are not involved. Patients using the self-administered pen device, Levemir FlexPen®, should expect shortages beginning as soon as January 2024, because pens will be phased out by April. The vial form of Levemir will no longer be available by the end of 2024. Prescribers and patients can work together to find alternative insulins. Other long-acting insulins, which include insulin glargine (Basaglar®– Eli Lilly and Company, Lantus® – Sanofi, Semglee® – Mylan and others) and insulin degludec (Tresiba® – Novo Nordisk) are not affected by the discontinuation.
Aliqopa Being Withdrawn
Based on a single-arm, Phase II clinical trial of 104 patients, Aliqopa (copanlisib – Bayer) received the FDA’s Accelerated Approval in September 2017. It was indicated for treating adults who have relapsed follicular lymphoma (rFL) that had been treated with at least two previous systemic therapies. A phosphatidylinositol-3-kinase (PI3K) inhibitor, it has specific activity against PI3K-alpha and PI3K-delta, which are overexpressed in malignant B cells. Full approval depended on further positive results from continuing clinical studies. Due to data that do not show an advantage for Aliqopa as compared to standard therapy for rFL, Bayer has now decided to remove Aliqopa from the market. The company will work with prescribers and patients to maintain an adequate supply of the drug for patients currently responding to treatment with it. Several other drugs that include a cytotoxic CD20-directed antibody, Gazyva® (obinutuzumab) IV injection along with an IV injected alkylating agent, bendamustine; an oral methyltransferase inhibitor, Tazverik® (tazemetostat) tablets; and the combination of the CD20-directed antibody, Rituxan® (rituximab) IV injection with the thalidomide analog, lenalidomide capsules; are FDA approved to treat rFL. Additionally, the chimeric antigen receptor T-cell (CAR-T) therapies Breyanzi™ (lisocabtagene maraleucel), Kymriah™ (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel) are FDA approved as late-line treatment for some advanced types of rFL.