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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 1
January 1, 2023

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First Gene Therapy for Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer

On December 16, 2022, the U.S. Food and Drug Administration (FDA) approved Adstiladrin® (nadofaragene firadenovec-vncg) for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) in adult patients whose cancer has not responded to treatment with Bacillus Calmette-Guérin (BCG) therapy. Bladder cancer is a common form of cancer in which malignant cells grow in, and potentially destroy, the tissues of the bladder. Non-muscle-invasive bladder cancer (NMIBC) makes up nearly 80% of newly diagnosed bladder cancers. NMIBC tumors grow through the lining of the bladder but do not reach the muscle layer surrounding the bladder. In its earlier stages, this form of bladder cancer is often removed and then treated with BCG, a therapy administered into the bladder that prompts the body’s immune system to attack cancer cells. When unresponsive to BCG, patients are at a much higher risk of progression of the disease and the spread of cancer cells to other areas of the body. Limited treatment options exist for these patients. Adstiladrin® was granted Priority Review, Breakthrough Therapy and Fast Track designations by the FDA to address this critical need.

Adstiladrin® is a gene therapy intended for use in BCG-unresponsive patients. It uses adenoviruses to deliver instructions to the bladder cells to produce a protein with antitumor activity. The adenoviruses used for gene therapy do not replicate in human cells and do not cause infectious diseases. Adstiladrin® is administered directly into the bladder once every three months via a urinary catheter. The safety and effectiveness of Adstiladrin® were tested in a study of 98 patients, and the therapy was administered for up to 12 months. A complete response to the drug was defined as the disappearance of all signs of cancer seen in biopsied tissue, bladder scope and urine. In the study, 51% of patients receiving Adstiladrin® therapy achieved a complete response for an average of 9.7 months and, of those 46% (23% of the initial group) continued to show no signs of cancer for at least one year. The most common adverse reactions reported were bladder discharge and spasms, urgent and painful urination, presence of blood in urine, chills, fever and fatigue.

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Drug Safety

Recall of Three Lots of COVID-19 At-Home Test Kits

On December 12, 2022, the FDA announced Detect, Inc.’s voluntary recall of specific lots of their over-the-counter nasal swab COVID-19 rapid tests. The Detect Covid-19 Test™ was granted Emergency Use Authorization from the FDA in October 2021 to allow greater accessibility to at-home COVID-19 detection. The recalled lots have an increased risk of providing false negative results, which could lead infected individuals to believe they are not infected with the virus. These individuals may unknowingly spread the virus to others if they are not taking the necessary precautions. The accuracy of a positive test result has not been affected by this defect. The recalled lots are HB264, HY263 and HY264, and all have a “Use By” date of January 1, 2023. A total of 11,102 tests are included in this recall and were sold between July 26 and August 26, 2022. Detect, Inc. is notifying customers who have been affected by this recall and recommends that unused tests from these lots be disposed of. The company will issue refunds for the affected tests upon confirmation of disposal. To date, there have been no reports of false negative results, but Detect, Inc. has voluntarily recalled these lots out of caution. 

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From the Pharmaceutical Industry

Decreased Measles Vaccination Rates Associated with Increased Infection Rate

On November 23, 2022, the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) shared a press release regarding the increased threat of measles resulting from decreased vaccination rates. The measles vaccination, MMR, provides coverage against measles, mumps and rubella infections. Measles is one of the most contagious human viruses but receiving this vaccination can greatly decrease risks and usually provides lifetime coverage against this infection. Children require 2 doses of the MMR vaccine, with the first dose given between 12 and 15 months and the second dose given between 4 and 6 years. If not previously immune to measles, older children, adolescents and adults require 1 or 2 doses of the MMR vaccine. The vaccine is not recommended for individuals who have a weakened immune system or severe vaccine allergies or for those who are pregnant, so widespread vaccinations are imperative for developing herd immunity to protect these individuals from the virus. Since the beginning of the COVID-19 pandemic, MMR vaccination rates have steadily declined with nearly 40 million children missing one or both of their scheduled vaccine doses. Immunization activities have been disrupted by COVID-related interruptions in health care visits, parental decisions to decline vaccinations for their children and weakened measles vaccination and surveillance programs. This has left millions of children and at-risk individuals susceptible to infection, resulting in 9 million cases of measles and 128,000 deaths from measles worldwide in 2021 alone. According to the WHO, 10 countries that had eliminated measles had outbreaks and a reemergence of transmission since 2016. These trends represent an extreme setback in global progress toward measles elimination. The MMR vaccine is readily accessible and can be administered at most doctors’ offices and pharmacies. The CDC and WHO urge health care providers to identify and immunize unprotected children that have missed one or both necessary doses. On a larger scale, it is recommended that countries and global stakeholders elevate their vaccination surveillance systems, which would increase ability to detect outbreaks and respond quickly and effectively.

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FDA Approvals

New FDA Approvals

Orphan Drug Approval: Krazati® (adagrasib)

Oral tablet approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with a susceptible KRAS G12C mutation. [12/12/2022 – MIRATI THERAPEUTICS, INC]

Orphan Drug Approval:  Rezlidhia™ (olutasidenib)

Oral capsule approved for the treatment of acute myeloid leukemia in adult patients with a susceptible IDH1 mutation. [12/01/2022 – RIGEL PHARMACEUTICALS, INC]

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New Generics

New Generics Entering the Marketplace

*As of this issue, there were no new generics entering the marketplace.