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Clinical Insights: November 22, 2023

Posted on November 22, 2023 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug/Vaccine Approval

Truqap™ (capivasertib) Tablets – New Drug Approval – November 16, 2023 – AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. The approval by the Food and Drug Administration (FDA) was based on the results from the CAPItello-291 Phase III trial published earlier this year in The New England Journal of Medicine. <Read More>

Augtyro™ (repotrectinib) Capsules – New Drug Approval – November 15, 2023 – The Food and Drug Administration approved repotrectinib (Augtyro™, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve. Approval was based on TRIDENT-1, a global, multicenter, single-arm, open-label, multi-cohort clinical trial (NCT03093116) which included patients with ROS1-positive locally advanced or metastatic NSCLC. <Read More>

DefenCath™ (taurolidine and heparin) Catheter Lock Solution – New Drug Approval – November 15, 2023 – The U.S. Food and Drug Administration has approved Defencath™ (taurolidine and heparin) catheter lock solution (CLS) to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis (HD) through a central venous catheter (CVC). Defencath™ is indicated in this limited and specific patient population. Defencath™ CLS is available as a sterile, preservative-free, clear, aqueous-based solution in 3ml and 5ml dosages. Additional details about dosage and administration are detailed in the prescribing information. <Read More>

New Indication/Dosage/Formulation Approval

Xtandi® (enzalutamide) Capsules and Tablets – New Label Expansion – November 16, 2023 – Astellas Pharma Inc. and Pfizer Inc announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for Xtandi® (enzalutamide), following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, Xtandi® becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with Xtandi® with or without a gonadotropin-releasing hormone (GnRH) analog therapy. <Read More>

Keytruda® (pembrolizumab) for Injection – New Label Expansion – November 16, 2023 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Efficacy was evaluated in KEYNOTE-859 (NCT03675737), a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 1579 patients with HER2-negative advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for metastatic disease. <Read More>

Exparel® (bupivacaine liposome) Injectable Suspension – New Label Expansion – November 9, 2023 – Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to expand the Exparel® (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa. An adductor canal block is used for anesthesia and analgesia for surgery of the knee, medial lower leg, and ankle surgeries. A sciatic nerve block in the popliteal fossa is used for anesthesia and analgesia for foot, ankle, achilles tendon, and other lower leg surgeries. <Read More>

New Drug Shortage

November 15, 2023

Updated Drug Shortage

November 15, 2023

November 14, 2023

November 13, 2023

New Drug Recall and Safety Alerts

Pain and Fever Products by KinderFarms, LLC – New Voluntary Recall – November 17, 2023 – KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. The two products were manufactured and packaged for KinderFarms by a major, U.S.-based OTC pharmaceutical manufacturer with over 30 years of experience. <Read More>

Various Eye Drops by Kilitch Healthcare India Limited – New Voluntary Recall – November 15, 2023 – Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November, 2023 to September, 2025 for all the below mentioned products. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Specialty Pharmacy Partnership Can Be Fertile Ground – November 20, 2023 – Patients in Oklahoma receive specialty fertility medications more quickly and at less cost than they did before, thanks to a two-year partnership between OU Health University of Oklahoma Medical Center and Clearway Health, a Boston-based consultancy that helps health systems strengthen their specialty pharmacy offerings. But before embarking on the fertility initiative, OU Health had to shore up its overall approach to specialty pharmacy. A few key goals were to provide service at the lowest cost, with ongoing concierge-style support that speeds up prior authorizations and efficiently links patients to their pharmacists, noted Jigar Thakkar, PharmD, MBA, MHCDS, FACHE, the chief administrative officer for OU Health. <Read More>

Global Measles Threat Continues to Grow as Another Year Passes With Millions of Children Unvaccinated – November 16, 2023 – Following years of declines in measles vaccination coverage, measles cases in 2022 have increased by 18%, and deaths have increased by 43% globally (compared to 2021). This takes the estimated number of measles cases to 9 million and deaths to 136,000 – mostly among children – according to a new report from the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). Measles continues to pose a relentlessly increasing threat to children. In 2022, 37 countries experienced large or disruptive outbreaks compared with 22 countries in 2021. Of the countries experiencing outbreaks, 28 were in the WHO Region for Africa, six in the Eastern Mediterranean, two in Southeast Asia, and one in the European Region. <Read More>

CDC and FDA Expedite the Availability of Additional Doses of New RSV Immunization for Infants – November 16, 2023 –  CDC announced the release of more than 77,000 additional doses of Beyfortus™ (nirsevimab-alip (100 mg), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease. These additional doses will be distributed immediately to physicians and hospitals through the Vaccines for Children Program and commercial channels – improving the availability of nirsevimab-alip for parents seeking to protect their eligible children, particularly those at highest risk of severe illness. CDC and FDA will continue to be in close contact with manufacturers to ensure the availability of additional doses through end of this year and for early 2024 to meet the demand. <Read More>

Bots Deliver Time Back to Pharmacists – November 15, 2023 – Drones, robots and automated technologies are increasingly deployed across the healthcare landscape to speed workflows and improve efficiency. For pharmacists, amid a nationwide staffing shortage, tech is allowing them to work at the top of their license and serve more patients. ChristianaCare’s Christiana Hospital in Newark, Del., St. Elizabeth Fort Thomas (Ky.) Hospital and Dartmouth Hitchcock Medical Center in Lebanon, N.H., are three systems now utilizing new technology to free up pharmacists’ time, according to a Nov. 14 news release from the American Society of Health-System Pharmacists. <Read More>

Federal Solution to PBM Clawbacks is Backfiring – November 15, 2023 – Pharmacies have long faced “clawback fees” from pharmacy benefit managers, and a federal answer to the issue is causing another problem, KFF Health News reported Nov. 15. A new rule set for Jan. 1 will require PBMs to capture most of their fees when prescriptions are filled — rather than clawing them back after months or years. In anticipation of this change, pharmacies say the PBM industry is pressuring them into new contracts with severe cuts to their dispensing payments. <Read More>

Expanded Access to Clofazimine – November 15, 2023 – Clofazimine is approved for the treatment of leprosy under the commercial name Lampreneâ, manufactured by Novartis, but it has not been available in U.S. pharmacies since 2004, after marketing was discontinued. Currently, individuals are able to obtain access to clofazimine for the treatment of leprosy from the National Hansen’s Disease Program. Under certain circumstances, patients may be able to obtain access to clofazimine for the treatment of non-tuberculous mycobacterial (NTM) infections or other infections, uses for which clofazimine does not have FDA approval, from Novartis. <Read More>

340B in the News

What Makes a Patient a “Patient”? Court Rejects Restrictive 340B Definition – November 16, 2023 – On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The court concluded that the government’s restrictive interpretation of the term was contrary to the plain language of the 340B Statute and would frustrate the goals of the 340B Program. In reaching this conclusion, the court focused on common definitions of the term “patient,” as well as the structure and congressional intent of the 340B Statute, to support a “broad reading” of the term “patient.” The court enjoined the Health Resources and Services Administration (HRSA) from enforcing its more restrictive interpretation of the term against the plaintiff, a federally funded health center. Although this decision may bring this years-long litigation to an end, Genesis raises a host of new questions for 340B Program stakeholders, including the applicability of the decision to other covered entities, the practical import of the decision in enforcement actions, and how the court’s analysis will alter covered entity and manufacturer compliance with HRSA and Apexus guidance. <Read More>