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Monthly News Roundup - February 2024

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on March 1, 2024.

Tecvayli Approved for Biweekly Dosing in Multiple Myeloma

In February, the U.S. Food and Drug Administration (FDA) approved biweekly (every 2 weeks) dosing for Tecvayli (teclistamab-cqyv) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of 6 months. Previously it was approved only for once weekly dosing.

• Tecvayli, from Janssen Pharmaceuticals, is used to treat multiple myeloma (bone marrow cancer) in adults who have not responded to at least 4 prior treatments (including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody), or who have relapsed despite prior treatments.
• It is classified as a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager. It works by binding to cancer cells, allowing the immune system to better recognize and attack the malignant cells.
• Approval is based on results from the Phase 1/2 MajesTEC-1 study with 165 participants. When patients achieved a confirmed CR or better for 6 months or longer on once weekly dosing of 1.5 mg/kg, they were then eligible to reduce dosing frequency to 1.5 mg/kg biweekly until disease progression or unacceptable toxicity.
• Tecvayli is given as a subcutaneous (under the skin) injection. A healthcare provider determines the weight-based dose. Initially, the medicine is given as a step-up dose to help lower the risk of serious side effects.
• Tecvayli is only available through the Tecvayli Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of cytokine release syndrome (CRS) and neurologic problems.
• Tecvayli carries a Boxed Warning for possibly fatal Cytokine Release Syndrome (CRS) and neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
• Common side effects (≥20%) include fever (pyrexia), cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.

Biktarvy Indications Expanded to Include People with HIV Resistance

Biktarvy (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) is now approved by the FDA for people with HIV who have a known or suspected M184V/I mutation, a common form of HIV treatment resistance. The M184V/I resistance mutation is present in 22% to 63% of people with HIV with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs).

• Biktarvy contains an integrase strand transfer inhibitor (bictegravir) and the nucleoside analog reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide (Descovy) for the treatment of HIV-1 infection in adults and children.
• Approval was based on data from a 48-week, Phase 3 study (study 4030) in people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Subjects were randomized to switch to Biktarvy (N=284) or to continue their prior treatment regimen, dolutegravir (DTG) + F/TAF (N=281). Of the subjects receiving Biktarvy, 47 had HIV-1 with pre-existing M184V or I resistance substitutions.
• Participants must have been stably suppressed (HIV-1 RNA less than 50 copies/mL) on their baseline regimen for at least 6 months (if documented or suspected NRTI resistance), or at least 3 months (if no documented or suspected NRTI resistance) prior to trial entry. At Week 48, 0.4% (1/284) participants in the Biktarvy group had HIV-1 RNA ≥50 copies/mL, compared to 1.1% (3/281) in the DTG+F/TAF group (difference -0.7% [95%CI: -2.8%, 1.0%])
• Data showed that 89% (42/47) of people receiving Biktarvy (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) with preexisting M184V/I resistance substitutions remained virally suppressed (HIV-1 RNA < 50 copies/mL) at Week 48 of the study. Eleven percent (5/47 subjects) had no data at Week 48 due to study drug discontinuation.
• No cases of treatment-emergent resistance to Biktarvy were shown, regardless of M184V/I resistance status. Safety data did not differ from studies in people with no antiretroviral treatment history.

Simlandi Cleared as the Third Interchangeable Biosimilar to Humira

In February, the FDA approved Simlandi (adalimumab-ryvk), a tumor necrosis factor (TNF) blocker interchangeable biosimilar to Humira for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• An interchangeable biosimilar can automatically be substituted for the reference product (in this case, Humira) by a pharmacist, depending upon state laws. The pharmacist will not need to contact the doctor to get an approval. It also means the reference biologic and the new biosimilar can be switched back and forth in a patient without a risk of changes in safety or effectiveness.
• Interchangeable products should be more affordable, more likely to be covered by insurance and make it easier for patients to access a biologic medicine.
• Approval of Simlandi is based on clinical data that demonstrates Simlandi is biosimilar to Humira. It is available as a citrate free formulation in a 40 mg/0.4 mL single-dose autoinjector.
• The most common adverse reactions (>10%) are infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.
• Simlandi is the tenth FDA-approved Humira biosimilar and is manufactured by Alvotech and Teva Pharmaceutical Industries Ltd. The other approved interchangeable biosimilars for Humira are Cyltezo (interchangeable status granted October 18, 2021) and Abrilada (interchangeable status granted October 5, 2023).

Xolair Use Expanded to Reduce Accidental Food Allergies

This past month the FDA approved Xolair (omalizumab) injection to help reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. It is the first FDA-approved medicine to reduce allergic reactions in people with multiple food allergies.

• Xolair is classified as an anti-IgE monoclonal antibody. This marks the 4th approval for Genentech’s Xolair, after allergic-type asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.
• Approval is based on positive data from the Phase III OUtMATCH 16 to 20 week study, which evaluated Xolair in patients aged 1 to 55 years allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut. A significantly higher proportion of patients treated with Xolair compared to placebo tolerated all food proteins without moderate to severe allergic symptoms.
• For peanuts, patients tolerated at least 600 mg of peanut protein compared to 5% of those treated with placebo (p<0.0001). This amount is equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter.
• The dose of Xolair for IgE-mediated food allergy is 75 mg to 600 mg given as an injection under the skin (subcutaneous) every 2 or 4 weeks. The exact dose is determined based on body weight and serum total IgE level (IU/mL). People taking Xolair for food allergies should continue to avoid all foods to which they are allergic.
• Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis, as well as acute bronchospasm or status asthmaticus.
• The most common adverse reactions (≥3% of patients) were injection site reactions and fever (pyrexia).

FDA Grants Accelerated Approval to Amtagvi for Advanced Melanoma

This past month the FDA approved Amtagvi (lifileucel) from Iovance Biotherapeutics for the treatment of adults with metastatic melanoma (advanced skin cancer) that cannot be removed surgically or has spread to other parts of the body. Patients eligible for this treatment have been previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

• Amtagvi, a tumor-derived autologous T-cell immunotherapy, is the first one-time, individualized T-cell therapy to receive FDA approval for a solid tumor cancer. It is made from a portion of the surgically removed tumor yielding billions of tumor-derived T cells.
• Amtagvi is thought to work by deploying patient-specific T-cells called TIL cells from the immune system that locate, attack and destroy the cancer. TIL cells recognize tumor markers on the cell surface of each person’s cancer.
• Approval is based on results from the C-144-01 clinical trial. Among 73 patients, 31.5% achieved an objective response (Response Evaluation Criteria in Solid Tumors, RECIST 1.1) with a median duration of response not reached at 18.6 months follow-up (43.5% of responses had a duration greater than 12 months).
• A single IV infusion dose of Amtagvi contains 7.5 × 109 to 72 × 109 viable cells. Patients will receive Amtagvi from Authorized Treatment Centers (ATCs) and typically require hospitalization.
• The most common side effects include chills, fever, low red or white blood cell count fatigue, fast or irregular heartbeat, rash, low blood pressure, and diarrhea, among others.
• This indication is approved under accelerated approval based on objective response rate. Continued approval of Amtagvi for this use may depend on the results of an ongoing study to confirm benefit.

FDA Approves Aurlumyn as the First Medication to Treat Severe Frostbite

Aurlumyn (iloprost) injection is now approved by the FDA to treat severe frostbite in adults to reduce the risk of finger or toe amputation. Aurlumyn, from Eicos Sciences, works by binding with human prostacyclin and prostaglandin EP1 receptors and acts as a vasodilator (a drug that opens blood vessels) and helps to prevent blood clotting.

• Iloprost is a synthetic analog of prostacyclin PGI2. It is given as a continuous intravenous (IV) infusion for 6 hours each day up to a maximum of 8 consecutive days to treat severe frostbite.
• Approval was based on an open-label, controlled trial that randomized 47 adults with severe frostbite. All participants were treated with rapid rewarming, 250 mg aspirin IV, and buflomedil 400 mg IV and then randomized to 3 treatment groups. Buflomedil, not approved in the U.S, is a vasodilator (an alpha-adrenoceptor antagonist / calcium channel blocker) used to treat claudication and peripheral arterial disease.
• Participants in the 3 groups received either buflomedil 400 mg IV for up to 8 days, iloprost IV for 6 hours daily for up to 8 days, or recombinant tissue plasminogen activator IV on Day 1 and iloprost IV for 6 hours daily for up to 8 days. All patients continued to receive daily aspirin and standard of care for up to 8 days.
• Bone scan results on day 7 showed the predictive need for amputation (of at least one finger or toe) was 0% (0 of 16) for patients receiving iloprost alone compared to 19% (3 of 16) for patients receiving recombinant tissue plasminogen activator IV / iloprost, and 60% (9 of 15) for patients receiving buflomedil. The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost.
• Aurlumyn carries a warning for symptomatic hypotension (low blood pressure). The most common side effects of Aurlumyn include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, and hypotension.
• Iloprost (Ventavis) was originally approved in 2004 as a nebulized inhalation treatment for pulmonary arterial hypertension.

FDA Approves Eohilia, a Novel Dosage Form to Treat Eosinophilic Esophagitis

This past month the FDA approved Takeda’s Eohilia (budesonide oral suspension), a novel muco-adherent formulation of the corticosteroid budesonide used for the treatment of eosinophilic esophagitis (EoE). Eohilia is indicated for 12 weeks of treatment in patients 11 years and older with EoE.

• Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the ​​esophagus that can lead to a variety of symptoms, including difficulty swallowing, vomiting and pain.
• Eohilia exhibits thixotropic properties, allowing it to flow more freely when shaken and returning to a more viscous state when swallowed. The recommended dose is 2 mg orally twice daily for 12 weeks.
• Approval was based on two 12-week long studies where patients received Eohilia 2 mg or placebo twice daily. Significantly more patients receiving Eohilia achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%, respectively). In Study 2, 38% of Eohilia patients achieved histologic remission vs. 2.4% of those in the placebo group. Dysphagia (trouble swallowing) also improved more in the Eohilia group vs. placebo in the last 2 study weeks as measured by the patient-reported Dysphagia Symptom Questionnaire (DSQ).
• The most common adverse reactions (≥2%) are respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression and erosive esophagitis.

Exblifep Antibacterial OK’d to Treat Complicated Urinary Tract Infections

Exblifep (cefepime and enmetazobactam) injection, from Allecra Therapeutics, is a new fourth generation cephalosporin + beta lactamase inhibitor combination approved for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years of age and older.

• Exblifep was designed to combat antimicrobial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs).
• Cefepime works by inhibition of bacterial cell wall synthesis and enmetazobactam blocks the activity of beta-lactamase enzymes, preventing the degradation of beta-lactam antibiotics. Beta lactamase inhibitors have little antibiotic activity on their own.
• Approval was based on the Phase 3 ALLIUM trial which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam (Zosyn) in the primary composite outcome of clinical cure and microbiological eradication in patients with cUTIs.
• Exblifep is administered as 2.5 grams (2 grams cefepime / 0.5 grams enmetazobactam) every 8 hours by intravenous (IV) infusion over 2 hours for 7 to 14 days. Dosage adjustment is recommended in patients who have an eGFR < 60 mL/min or > 130 mL/min.
• Warnings include hypersensitivity reactions, neurotoxicity and Clostridioides difficile-associated diarrhea. Most cases of neurotoxicity occurred in patients with renal impairment who did not receive appropriate dosage adjustment of cefepime, and the elderly are at an increased risk.
• The most common adverse reactions (≥5%) include elevated liver enzymes, increased bilirubin, headache, and phlebitis / infusion site reactions.

Posted February 2024

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