Monthly Archives: November 2023

The U.S. Food and Drug Administration has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or post marketing adverse event (AE) data sources.

FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class (listed alphabetically by trade name) include the following:

• Abecma (idecabtagene vicleucel)
• Breyanzi (lisocabtagene maraleucel)
• Carvykti (ciltacabtagene autoleucel)
• Kymriah (tisagenlecleucel)
• Tecartus (brexucabtagene autoleucel)
• Yescarta (axicabtagene ciloleucel)

Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and evaluating the need for regulatory action.

Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies. In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene.

To report suspected adverse events including T cell malignancies, contact the FDA at 1-800-FDA 1088 or www.fda.gov/medwatch.

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The U.S. Food and Drug Administration is warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, we are requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.

This hypersensitivity reaction to these medicines is serious but rare. DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas.

What is FDA doing?

The FDA is requiring manufacturers of these medicines to add new warnings about DRESS to the prescribing information and the Medication Guide for patients and caregivers. For levetiracetam (Keppra, Keppra XR, Elepsia XR, and Spritam), this involves adding a new warning in the Warnings and Precautions section of the prescribing information, which describes the most serious and significant potential safety issues. Currently the symptoms associated with this condition are described less prominently.

For clobazam (Onfi and Sympazan), the FDA is requiring a new warning specifically about DRESS to be added to the prescribing information. Symptoms related to this risk are already described more generally in other sections of the clobazam prescribing information.

FDA reviewed worldwide cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with levetiracetam and clobazam in children and adults reported to the FDA Adverse Event Reporting System (FAERS) database and can be found in the medical literature.

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FDA Approves Ogsiveo for Adults with Desmoid Tumors

SpringWorks Therapeutics, Inc., announced today that the U.S. Food and Drug Administration has approved Ogsiveo™ (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. The FDA previously granted breakthrough therapy, fast track, and orphan drug designations to nirogacestat for the treatment of desmoid tumors.

Desmoid tumors are locally aggressive and invasive soft-tissue tumors that can lead to substantial morbidity. In addition, when vital structures are impacted, desmoid tumors can be life threatening. Although they do not metastasize, desmoid tumors are often refractory to existing off-label systemic therapies and associated with recurrence rates of up to 77% following surgical resection. Desmoid tumor experts and treatment guidelines now recommend systemic therapies as first-line intervention instead of surgery for most tumor locations requiring treatment.

Ogsiveo (nirogacestat) is not approved for the treatment of any other indication in the United States, or for any indication in any other jurisdiction by any other health authority.

SpringWorks is also evaluating nirogacestat as a potential treatment for patients with ovarian granulosa cell tumors and for patients with multiple myeloma as part of several B-cell maturation agent (BCMA) combination therapy regimens in collaboration with leaders in industry and academia.

SpringWorks expects to file a Marketing Authorization Application for Ogsiveo in desmoid tumors with the European Medicines Agency in the first half of 2024.

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Botanical-Be is voluntarily recalling all lots of Kuka Flex Forte Capsules, Artri King, Capsules, and Reumo Flex Capsules to the consumer level. FDA analysis has found the Kuka Flex Forte Capsules, Artri King Capsules, and Reumo Flex Capsules, to be tainted with Diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug (NSAID), however, the presence of Diclofenac in Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses. To date, Botanical-Be has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and are packaged as followed:

• Artri King distributed in the bottles with 100 capsules.
• Kuka Flex distributed in the bottles with 30 capsules.
• Reumo Flex distributed in the boxes with 30 capsules.

The affected product lots include the following lot numbers and expirations: Artri King lot 35421, with an expiration date of December 19, 2025; Kuka Flex Forte; all lots with an expiration date of December 12, 2024, and UPC code 0736640810265; Reumo Flex; all lots with an expiration date of October 20, 2024.

These products were distributed nationwide via the internet. Botanical-Be is notifying its customers via email and is arranging for the return of all recalled products.

Consumers in possession of these products should cease usage immediately and return them to the place of purchase.

For any queries related to this recall, consumers can contact Botanical-Be by phone at (915) 412-6237 or by e-mail at botanical.be@gmail.com on Monday to Friday from 8:00 am to 5:pm, Mountain standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

(BeneCard does not carry the noted manufactured drugs)

FDA Approves Ryzneuta® for Chemotherapy-Induced Neutropenia

Evive Biotech (Evive), and Acrotech Biopharma (Acrotech), a subsidiary of Aurobindo Pharma USA Inc., have announced that the U.S. Food and Drug Administration has approved Ryzneuta®. Ryzneuta (Efbemalenograstim alfa), is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neutropenia is a common side effect of chemotherapy and is characterized by persistently low levels of neutrophils (a type of white blood cell with infection-fighting functions) due to the use of chemotherapy and other types of anti-cancer drugs, which increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy.

Ryzneuta is a novel long-acting Granulocyte colony-stimulating factor (G-CSF), which can stimulate the proliferation, differentiation, and release of neutrophil precursors. It helps to enhance the immune function of cancer patients and to prevent the side effects of neutropenia caused by chemotherapy.

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FDA Approves Maxigesic® IV to be Marketed in the U.S. as Combogesic® IV (acetaminophen and ibuprofen) for the Management of Pain

October 18, 2023 – Hyloris Pharmaceuticals SA), today announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.

The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.

Distribution of Combogesic® IV in U.S. hospitals should start in early 2024.

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FDA Approves Truqap plus Faslodex for Patients with Advanced HR-Positive Breast Cancer

AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the U.S. 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.

Breast cancer is the most common cancer and one of the leading causes of cancer-related death worldwide. HR-positive breast cancer (expressing estrogen or progesterone receptors, or both), is the most common subtype, with more than 65% of tumors considered HR-positive and HER2-low or HER2-negative. More than two million patients were diagnosed with breast cancer in 2020, with nearly 685,000 deaths globally. In the US, more than 290,000 patients are expected to be diagnosed in 2023, with more than 43,000 deaths.

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FDA Approves Augtyro™ for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

Bristol Myers Squibb has announced that the U.S. Food and Drug Administration approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Administered as an oral therapy, Augtyro capsules are administered once daily for 14 days, then twice daily, with or without food. It is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.

Lung cancer is the leading cause of cancer deaths in the United States. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) represents up to 85% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed.

Augtyro is designed to minimize interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients. It is expected to be available to patients in the U.S. in mid-December 2023.

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FDA Approves DefenCath® (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients

CorMedix Inc has announced that the U.S. Food and Drug Administration has approved DefenCath (taurolidine and heparin) catheter lock solution (CLS).

DefenCath has been shown to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.

Catheter-related bloodstream infections are common in patients with central venous catheters. Approximately 80% of patients starting hemodialysis will have a CVC inserted for vascular access. CRBSI’s can occur in up to a third of HD-CVC patients. Each year, ~250,000 CRBSIs occur in patients with an intravascular device, such as central venous catheters (CVCs), leading to death in about one in four patients infected. CRBSIs can lead to more hospital admissions, longer stays, and long-term complications such as cardiovascular events.

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FDA Approves First Treatment for Congenital Thrombotic Thrombocytopenic Purpura

Takeda today announced that the U.S. Food and Drug Administration has approved Adzynma (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). Adzynma is the first and only FDA approved recombinant ADAMTS13 (rADAMTS13) protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.

Congenital TTP is a blood disorder characterized by low platelets, low red blood cell count (caused by premature breakdown of the cells), abnormalities in kidney function, and neurological abnormalities. A similar clinical condition with overlapping features is hemolytic-uremic syndrome.

Adzynma is a purified recombinant form of the ADAMTS13 enzyme that enhances the low levels of the deficient enzyme in patients with cTTP. For prophylactic ERT, Adzynma is administered intravenously once every other week. For on-demanhttps://www.drugs.com/adzynma.htmld ERT, it is administered once daily. The most common side effects included headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness, and vomiting.

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