Therakind received approval on Nov. 29, 2022, for Jylamvo® (methotrexate) oral solution 2mg/mL. At varying doses and schedules, it is indicated for use in combination with other drugs to treat adults who have acute lymphoblastic leukemia (ALL) or non-Hodgkin’s lymphoma (NHL). Additional indications are monotherapy for the treatment of adults who have mycosis fungoides, rheumatoid arthritis (RA), or severe psoriasis. A boxed warning cautions that it may injure an unborn baby, so it should not be used during pregnancy, and women who could become pregnant while taking it should be counseled to use effective forms of contraception. Also, taking Jylamvo may be associated with severe infections, nerve damage, secondary cancers, infertility, and other serious side effects. Patients should be monitored closely for any signs of adverse events. Numerous other injectable and oral methotrexate products that are available in the United States include Xatmep® (methotrexate) oral solution 2.5mg/mL, which currently is approved only for treating children who have ALL. Launch plans and costs for Jylamvo have not yet been released. Look here for its full prescribing information.
Pediatric Indication Extended for Bivalent COVID Vaccines
The FDA expanded the emergency use authorizations (EUAs) for the most recent (bivalent) versions of COVID-19 vaccines from both Moderna and Pfizer/BioNTech to children as young as six months old on Dec. 8, 2022. Now, children from six months old up to five years old who have been vaccinated with two primary doses of the original (monovalent) form of Moderna’s vaccine can be boosted with the bivalent version of the same product as long as the last of their two original shots was at least two months ago. Similarly, children between six months old and four years old who already have received two doses of Pfizer/BioNTech’s monovalent vaccine can get the bivalent version as the third dose in their primary series of vaccinations at eight weeks or more after the second dose. But children who already have had a third monovalent Pfizer/BioNTech shot should not get a bivalent booster until more information is available. Revised Fact Sheets for Moderna’s vaccines can be found here and updated ones for Pfizer/BioNTech’s are here. More information on the use of bivalent vaccines for young children is in this FDA notice.
First Generics for Treanda Powder
On Dec. 7, 2022, the FDA approved the first AP-rated generics to Teva’s Treanda® (bendamustine) lyophilized powder for injection, an alkylating agent used for treating adults with chronic lymphocytic leukemia (CLL) or indolent B-cell NHL. According to the agency’s website, two manufacturers, Dr. Reddy’s and Accord have received final FDA approval for generics for both the 25mg and 100mg vials. Several additional manufacturers have their generics listed as “tentatively approved” and have yet to secure final approval. IQVIA estimates that annual sales of Treanda powder amounted to approximately $69 million in the U.S. for 2021.
Pepaxto Withdrawal Requested
In February 2021, the FDA granted Accelerated Approval to Oncopeptides’ Pepaxto® (melphalan flufenamide) injection. It was approved for use, along with dexamethasone, to treat adult patients who have relapsed or refractory multiple myeloma, who had received at least four prior lines of therapy, and whose disease is refractory to specified previously used drug classes. Full approval was contingent upon clinical trial results that upheld Pepaxto’s advantage over other treatments. However, in October 2021, results from the OCEAN-3 clinical study showed that patients who received the Pepaxto regimen actually had a 4.2% higher risk of dying (47.6%) than patients who were using Pomalyst® (pomalidomide – Bristol Myers Squibb) and dexamethasone (43.4%). The average survival time was 19.7 months among the Pepaxto group vs. 25 months for those on Pomalyst. Therefore, Pepaxto was withdrawn from sale in the U.S. at that time, and it has remained off the market since then. In early 2022, Oncopeptides decided to resubmit it for full FDA approval on the basis of Oncopeptide’s reassessment for subgroup analysis of the study results, which they believed proved Pepaxto’s benefit for certain types of patients. In September 2022, an FDA Advisory Committee questioned the validity of the new analysis and almost unanimously voted against approval. Agreeing with the committee’s recommendation, the FDA formally asked Oncopeptides on Dec. 7, 2022, to withdraw Pepaxto’s marketing authorization. The company announced that they are evaluating options for a final decision early in 2023.