Monthly News Roundup - June 2025

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on June 30, 2025.

Dupixent Approved in the U.S. as the First Targeted Medicine to Treat Patients with Bullous Pemphigoid

Dupixent (dupilumab) has been approved for the treatment of adult patients with bullous pemphigoid (BP). BP is an autoimmune skin condition that primarily affects patients 65 years and older. It is characterized by intense itch, painful blisters and lesions, and skin reddening. It can be a long-lasting condition, resulting in patients being more prone to infection and disruption of their daily activities.

Dupixent works by blocking two interleukins (IL-4 and IL-13) to reduce inflammation that can lead to symptoms. Interleukins are small proteins that are made by white blood cells and other cells in the body that help regulate immune responses.
The recommended dosage for adults is an initial subcutaneous (under the skin) injection of 600 mg (two 300 mg injections), followed by 300 mg given every other week. Dupixent is used in combination with a tapering course of oral corticosteroids (OCS). It can be given in a clinic or at home by the patient after training by a healthcare professional.
Approval was based on results from the 52-week ADEPT trial, a randomized, Phase 2/3, double-blind, placebo-controlled trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. Patients received Dupixent or placebo every 2 weeks after an initial loading dose, along with OCS treatment. The primary endpoint was the proportion of patients achieving sustained disease remission (defined as complete remission and off OCS no later than Week 16, absence of disease relapse from the time of completion of the corticosteroid taper to Week 36, and absence of rescue therapy during the 36-week double-blind treatment period). In the Dupixent / OCS group, 18.3% achieved sustained disease remission vs. 6.1% in the placebo / OCS group. The proportion of subjects with a reduction of at least 4 points in patient-reported itch (Peak Pruritus numerical rating scale) from baseline, a secondary endpoint, was 38.3% in the Dupixent / OCS group vs. 10.5% in the placebo / OCS.
Warnings and precautions include severe allergic reactions, conjunctivitis and keratitis, and eosinophilic conditions, among others. The most common adverse events (in at least 2% of participants) included: joint pain, conjunctivitis, blurred vision, herpes viral infections and keratitis.
Dupixent is manufactured by Regeneron and Sanofi.

Mavyret Gains New Use as First Approval for Acute Hepatitis C Virus (HCV)

In June, the FDA expanded the indications for AbbVie’s Mavyret (glecaprevir and pibrentasvir) as the first approved treatment for acute hepatitis C virus (HCV). Mavyret can now be used in people 3 years and older with acute (recently infected) or chronic (long-lasting) hepatitis C virus (HCV) infection (genotypes 1-6) without cirrhosis or with compensated cirrhosis.

People with acute HCV may not have symptoms, but if left untreated, it can lead to liver-related complications, such as cirrhosis or liver cancer. Cirrhosis occurs when the liver tissue becomes scarred and damaged leading to impaired liver function. Compensated cirrhosis occurs in early stage HCV when the liver is still functioning and the person may have few or no symptoms of liver disease.
Mavyret is an oral combination direct-acting antiviral therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.
Approval was supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of 8 weeks of Mavyret in 286 treatment-naïve adults with acute HCV infection. Patients received oral Mavyret tablets once daily for 8 weeks, then were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12). The overall SVR12 rate was 96% (275/286); no subjects experienced virologic failure.
The most common adverse events were fatigue (3%), asthenia (weakness, 2%), headache (2%), and diarrhea (2%). Mavyret is not recommended in patients with moderate cirrhosis and should not be used in patients with severe cirrhosis or taking the drugs atazanavir or rifampin.
Mavyret is also approved to treat adults and children 3 years of age and older with HCV genotype 1 infection who have been previously treated with a regimen that contained an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

FDA Approves Merck’s Enflonsia for Prevention of Respiratory Syncytial Virus (RSV) in Infants

The FDA has cleared Enflonsia (clesrovimab-cfor) for passive immunization to prevent Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Enflonsia helps to protect healthy and at-risk infants from RSV complications and hospitalizations by providing rapid, long-lasting passive immunity against the respiratory syncytial virus (RSV).

RSV is a contagious virus that causes widespread seasonal infections and can lead to serious respiratory conditions such as bronchiolitis and pneumonia in infants.
Enflonsia is a long-acting monoclonal antibody (mAb) that works by preventing the virus from entering cells, multiplying, and causing infections.
Enflonsia is used in newborns and infants in their first RSV season from autumn to spring. It is administered as a single intramuscular injection (into the muscle). The safety and effectiveness of Enflonsia have not been established in children older than 12 months of age.
FDA approval was based on results from the Phase 2b/3 CLEVER trial which met its primary and secondary endpoints. Enflonsia demonstrated an 84.3% reduction in hospitalizations due to RSV and a 60.5% reduction in medically-attended lower respiratory infections (MALRI).
Warnings and precautions associated with Enflonsia include serious hypersensitivity (allergic) reactions, including anaphylaxis (a potentially life-threatening allergic reaction).
Common adverse reactions include injection-site redness (3.7%), injection-site swelling (2.7%) and rash (2.3%).

FDA Approves First-in-Class Andembry to Prevent Attacks of Hereditary Angioedema

The FDA has approved Andembry (garadacimab-gxii), an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) used to help prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. Factor XIIa is a plasma protein that plays a key role in attacks of swelling in people with HAE.

HAE is a rare, genetic and potentially life-threatening condition caused by a lack of or damaged C1INH, a protein in the blood that helps to control inflammation. Symptoms include painful, recurrent and unpredictable attacks of swelling (angioedema) that may affect the face, stomach area, larynx (voice box), and extremities like hands, arms and legs.
Andembry works in the prophylaxis of HAE by inhibiting factor XIIa, the first protein activated in the HAE pathway.
FDA approval was supported by data from the Phase 3, randomized, double-blind VANGUARD clinical trial. Patients aged 12 years and older with HAE type I or II receive a loading dose of 400 mg followed by 200 mg of Andembry monthly (n=39) or volume matched placebo monthly (n=25), given subcutaneously. Results showed that 62% of Andembry-treated patients remained attack-free throughout the treatment period. In addition, HAE attacks were reduced by a median of more than 99% compared to placebo.
Andembry is administered by subcutaneous injection (under the skin) once monthly. Andembry is supplied in prefilled, single-dose autoinjector and syringe dosage forms, allowing patients to self-administer the injections.
The most common adverse reactions (incidence ≥7%) are nasopharyngitis (common cold symptoms like runny nose and sore throat) and abdominal (stomach area) pain.
The ongoing open-label extension of the Phase 3 VANGUARD study is evaluating the long-term safety and efficacy of Andembry (200 mg monthly) for the prophylactic treatment of hereditary angioedema attacks.
Andembry is manufactured by CSL Behring LLC.

Gilead’s Yeztugo is First HIV PrEP Option with 6 Months of Protection

The FDA has approved Yeztugo (lenacapavir) for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1. Yeztugo is classified as an HIV capsid inhibitor, and at least 99.9% of participants remained HIV negative in Phase 3 studies.

Yeztugo is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo treatment.
Yeztugo works by interfering with HIV capsid, a protein shell that protects the genetic material of the HIV virus and the enzymes needed for replication. It is designed to inhibit HIV-1 at multiple stages of its lifecycle and may work against HIV strains that are resistant to other HIV drugs. It has no known cross resistance exhibited in vitro to other existing drug classes.
Individuals must have a negative HIV-1 test prior to initiating Yeztugo and prior to each subsequent injection. Initial dosing involves injections and tablets followed by injections once every 6 months. Day 1 dosing is 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2 dosing is 600 mg orally. Thereafter, injections are given once every 6-months (26 weeks) from the date of last injection (±2 weeks).
Approval was supported by the Phase 3 PURPOSE trials. PURPOSE 1 data showed that twice-yearly Yeztugo, given subcutaneous (under the skin) demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial there were two HIV infections among 2,179 participants in the Yeztugo group (99.9% HIV negative).
The most common adverse reactions in at least 5% of participants in studies were injection site reactions, headache, and nausea.
Lenacapavir injection was also approved in Dec. 2022 as Gilead’s brand product Sunlenca. It is used to treat resistant HIV-1 infections in adults when used together with other HIV-1 medicines in people who are failing treatment due to resistance, intolerance, or safety considerations.

Incyte’s Monjuvi Approved for Patients with Follicular Lymphoma

The FDA has approved a new indication for Monjuvi (tafasitamab-cxix), to be used in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). It was previously approved to treat adults with advanced diffuse large B-cell lymphoma (DLBCL) in July 2020.

Follicular lymphoma is a type of non-Hodgkins lymphoma that develops from a B cell lymphocyte (a type of white blood cell). The cells begin to grow and divide in abnormal or uncontrolled ways leading to cancer. Follicular lymphoma is an indolent lymphoma which means that it grows and spreads slowly.
Monjuvi is a targeted immunotherapy treatment that works by binding to CD19 markers expressed on the surface of pre-B and mature-B lymphocytes and several B-cell cancers, including DLBCL and FL. Once bound, Monjuvi signals the immune system to attack and destroy these cells. Monjuvi belongs to the drug class called CD19-directed cytolytic antibodies.
Approval was based on the Phase 3 inMIND trial evaluating the efficacy and safety of Monjuvi in combination with rituximab and lenalidomide in adult patients with relapsed or refractory FL. The primary endpoint of progression-free survival (PFS) was met. Patients receiving Monjuvi in combination with rituximab and lenalidomide achieved a median PFS of 22.4 months (95% CI, 19.2-not evaluable [NE]) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). The median duration of PFS follow-up was 14.1 months.
Results also showed 27.5% of patients with an event (disease progression, death) in the Monjuvi group vs. 47.6% of patients in the control arm. Disease progression was seen in 24% of those in the Monjuvi arm vs. 45.1% in the placebo group, and death in 2.9% vs. 2.5%, respectively. The overall response rate (complete plus partial response) was 84% in the Monjuvi group vs. 72% in the placebo control arm.
The most common side effects with Monjuvi include: feeling tired or weak, diarrhea, constipation, cough, rash, fever, swelling of lower legs or hands, respiratory tract infection, decreased appetite, low red and white blood cell counts, low platelet counts, and muscle or bone pain.

FDA Approves Oral Ibtrozi for Advanced ROS1-Positive Non-Small Cell Lung Cancer

The FDA has cleared Ibtrozi (taletrectinib), a new targeted drug therapy to treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Ibtrozi is a highly selective, central nervous system-active, next-generation oral ROS1 tyrosine kinase inhibitor (TKI).

About 2% of patients with NSCLC have ROS1-positive (ROS1+) disease, which occurs when the ROS1 gene fuses together with part of another gene causing uncontrolled cell growth and cancer. About 3,000 new diagnoses are made each year. ROS1+ NSCLC can be aggressive and brain metastases are common. Ibtrozi was designed to penetrate the central nervous system (CNS).
Approval was supported by the TRUST clinical program with 270 patients in multicenter, single-arm, open-label clinical trials. The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR).

In TRUST-I, TKI-naive patients, Ibtrozi achieved an ORR of 90% and an ORR of 85% in TRUST II. For TRUST-I, the longest DOR was observed at 46.9 months and ongoing, and for TRUST-II, DOR was 30.4 months and ongoing, as of October 2024. Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label.
In TRUST-I in TKI-pretreated patients, Ibtrozi achieved an ORR of 52% and median DOR of 13.2 months. In TRUST-II, Ibtrozi achieved an ORR of 62% and a median DOR of 19.4 months, as of October 2024.
In those with measurable CNS metastases, an intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24).

Ibtrozi capsules are taken by mouth once daily on an empty stomach, and continued until disease progression or unacceptable toxicity.
Warnings and precautions include liver toxicity, interstitial lung disease (ILD)/pneumonitis, QTc interval prolongation (an abnormal heart rhythm), hyperuricemia (high uric acid blood levels), myalgia (muscle pain, weakness) with creatine phosphokinase (CPK) elevation, bone fractures, and fetal harm.
Frequently reported adverse reactions / side effects (in at least 20% of patients) include diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue.
Ibtrozi is manufactured by Nuvation Bio Inc.

Keytruda Cleared for PD-L1+ Locally Advanced Head & Neck Cancer

Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by the FDA for the treatment of adults with locally advanced (has spread to nearby tissue or lymph nodes) head and neck squamous cell carcinoma (HNSCC) that can be removed by surgery and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test. This is Keytruda’s fourth approval for HNSCC indications, which included recurrent and metastatic disease that has spread to distant parts of the body.

For this use, Keytruda may be used alone as neoadjuvant treatment (given before surgery), then continued in combination with radiation with or without cisplatin after surgery, and then continued alone to help prevent your head and neck cancer from returning. It has been shown to reduce the risk of cancer recurrence, progression, or death by 30% when compared with standard of care chemoradiotherapy or radiotherapy alone (given after surgery).
Keytruda belongs to the drug group called immune checkpoint inhibitors. It works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda attaches to PD-1 receptors, preventing cell proteins PD-L1 and PD-L2 from binding and blocking the immune system's "brakes". This allows T cells (immune system cells) to deliver a stronger anti-cancer response and slow cancer growth.
For this use, it is given as an infusion over 30 minutes into your vein (IV infusion) every 3 or every 6 weeks, until disease progression, unacceptable toxicity, or up to 24 months.
Approval was based on the pivotal Phase 3 KEYNOTE-689 trial that showed a reduced risk of event-free survival (EFS) events (defined as disease recurrence, disease progression, or death) by 30% (HR=0.70 [95% CI, 0.55–0.89]; p=0.00140) in patients whose tumors expressed PD-L1 (CPS ≥1) compared to adjuvant standard of care (SOC). Among the CPS ≥1 population, median EFS was 59.7 months (95% CI, 37.9-not reached) in the Keytruda arm versus 29.6 months (95% CI, 19.5-41.9) in the SOC arm.
The median duration of exposure to Keytruda in the neoadjuvant phase was 3.1 weeks (range: 1 day to 4.9 weeks) and 42 weeks (range: 1 day to 82 weeks) adjuvant phase.
Warnings include immune-mediated adverse reactions. The most common side effects (in at least 20% of participants) in the Keytruda arm were mouth ulcers / stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), trouble swallowing / dysphagia (29%), constipation (27%), low thyroid levels (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and muscle / bone pain (22%).

New Tablet Formulation of Brukinsa Cleared for All Approved Indications

In June, BeOne Medicines announced the availability of a new oral tablet formulation of Brukinsa (zanubrutinib), used for all five FDA-approved indications. The Brukinsa tablets will replace the oral capsules starting in October 2025. Brukinsa is used to treat adults with mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia / small lymphocytic lymphoma and follicular lymphoma.

Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) and works by inhibiting the BTK protein and malignant B-cell proliferation.
Brukinsa tablets have the same efficacy and safety as Brukinsa capsules based on the results of 2 bioequivalence studies in healthy adults.
The recommended dosage is 160 mg orally twice daily or 320 mg orally once daily with or without food. Swallow whole with water.
The new scored tablets are 160 mg each, allowing patients to take two tablets daily instead of 4 of the current 80 mg capsules. If needed, the tablets can be split in half as prescribed by the healthcare provider. Brukinsa tablets are smaller than the capsules and have a film coating to help ease swallowing. It is the only BTK inhibitor to provide the flexibility of once or twice daily dosing.
In Brukinsa studies, the most common adverse reactions (≥30%), including laboratory abnormalities, are decreased neutrophil counts, decreased platelet counts, upper respiratory tract infection, hemorrhage (bleeding), and muscle and bone pain.
Brukinsa (zanubrutinib) was first approved in 2019. There is no generic option available on the U.S. market.

FDA Approves GSK’s Benlysta Autoinjector for Pediatric Lupus Nephritis

This past month the FDA cleared a 200 mg/mL autoinjector of Benlysta (belimumab) for subcutaneous injection (given under the skin) in patients 5 years of age and older with active lupus nephritis (LN) who are receiving standard therapy. This option can be used at home by caregivers after training.

Lupus nephritis is a complication of lupus and occurs when the immune system mistakenly attacks the kidneys, leading to inflammation and possible organ damage, which can lower the kidney’s ability to remove waste from the blood. Benlysta helps to modify an overactive immune response, improving symptoms such as fatigue and symptom flares.
Benlysta is classified as a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody. In lupus, B-cells are overactive and produce harmful autoantibodies that attack healthy tissue. Benlysta works by targeting and blocking the B-lymphocyte stimulator (BLyS) protein that helps B-cells survive and produce antibodies.
Benlysta is used for active systemic lupus erythematosus (SLE) or lupus nephritis in adults and children 5 years and older. It is given by subcutaneous (under the skin) injection or via an intravenous (into a vein) infusion.
Benlysta autoinjector dosage for active LN in children is weight-based and is given as a subcutaneous (under the skin) injection once a week OR once every 2 weeks. Caregivers can work with their child’s healthcare provider to decide if at-home administration via autoinjector is appropriate. The healthcare provider will provide caregiver instructions for home administration.
Common side effects for Benlysta include nausea, diarrhea, fever, sore throat, runny or stuffy nose (nasopharyngitis), bronchitis, trouble sleeping, pain in arms of legs, depression, migraine headache, and injection site reactions (with subcutaneous administration).

Posted June 2025

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