Monthly News Roundup - May 2025

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on May 31, 2025.

AbbVie’s Emrelis Approved for Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate now approved for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (≥50% of tumor cells with strong [3+] staining), who have received a prior systemic therapy.

Emrelis is classified as a c-Met-directed antibody-drug conjugate (ADC). ADCs work by targeting unique biomarkers such as the c-Met protein and deliver a potent 'payload' directly to the biomarker-expressing cell.
Accelerated approval was supported by the Phase 2 LUMINOSITY study. Findings showed that patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35% (95% CI: 24, 46) Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months (95% CI: 4.2, 12).
Emrelis is administered by intravenous (IV) infusion every two weeks until disease progression or unacceptable toxicity.
Warnings and precautions associated with Emrelis include peripheral neuropathy, interstitial lung disease (ILD)/pneumonitis, ocular surface disorders, infusion-related reactions (IRR), and embryo-fetal toxicity.
Common adverse reactions (≥20%) include peripheral neuropathy, fatigue, decreased appetite, peripheral edema (fluid accumulation, swelling) and laboratory abnormalities.
This accelerated approval is based on overall response rate (ORR) and duration of response (DOR) and continued approval may depend upon results from confirmatory trials.

Avmapki Fakzynja Co-Pack Gains Accelerated Approval for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

The FDA has granted accelerated approval to Verastem Oncology’s Avmapki Fakzynja Co-pack (avutometinib and defactinib), a kinase inhibitor combination, for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

Avmapki Fakzynja Co-Pack is classified as a RAF/MEK clamp and selective FAK inhibitor combination. It is the first and only FDA-approved medicine for KRAS-mutated recurrent LGSOC, a rare and highly recurrent cancer.
Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. Fakzynja (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib provides a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.
Accelerated approval is based on overall response rate (ORR) and duration of response (DOR). Efficacy was evaluated in RAMP-201 clinical trial, an open-label, multicenter study that included 57 adult patients. The major efficacy outcome measure, overall response rate (ORR), was 44% (95% CI: 31, 58) and the duration of response (DOR) range was 3.3 to 31.1 months. Continued approval may depend upon results from confirmatory trials.
As part of the co-pack, avutometinib is taken orally twice weekly (Day 1 and Day 4) for the first 3 weeks of each 4-week cycle and defactinib is taken orally twice daily for the first 3 weeks of each 4-week cycle. Treatment is continued until disease progression or unacceptable toxicity.
Serious side effects may include ocular (eye) disorders, skin toxicities (rash), liver toxicity, rhabdomyolysis (muscle toxicity), and fetal harm when administered during pregnancy.
The most common side effects include increased levels of an enzyme in the blood (CPK), nausea, fatigue, abnormal liver test (AST), and rash, among other possible lab changes and side effects.

GSK’s Nucala Approved for Use in Adults with Chronic Obstructive Pulmonary Disease (COPD)

Nucala (mepolizumab) is now approved as an add-on maintenance treatment for adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. It is not indicated for the relief of acute bronchospasm (sudden breathing problems).

Chronic obstructive pulmonary disease (COPD) is a long-term inflammatory lung disease that includes chronic bronchitis, emphysema, or both. It is the third leading cause of death worldwide. Patients experience ongoing symptoms such as breathlessness, cough, sputum and progressive airflow obstruction. Preventing exacerbations is a key goal of COPD management.
Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation.
Approval was based on data from the MATINEE and METREX phase 3, double-blind, studies ranging from 52 to 104 weeks. Nucala showed a clinically meaningful and statistically significant reduction in the annualized rate of moderate to severe exacerbations versus placebo in a wide spectrum of COPD patients with an eosinophilic phenotype.
Nucala is the only approved biologic evaluated in patients with an eosinophilic phenotype characterised by a blood eosinophil count (BEC) threshold as low as ≥150 cells/µL.
Warnings and precautions include hypersensitivity (allergic) reactions, herpes zoster infections, abrupt discontinuation of corticosteroids, and helminth (parasitic worm) infections.
In COPD studies, the most common adverse reactions (incidence ≥5%) included back pain, diarrhea, and cough.

Zoryve Topical Foam 0.3% Approved to Treat Plaque Psoriasis in People Ages 12 Years and Older

Zoryve (roflumilast) 0.3% is a steroid-free topical foam now approved to treat plaque psoriasis of the scalp and body in patients 12 years of age and older. The 0.3% cream was previously approved for plaque psoriasis in patients 6 years of age and older and is also approved for atopic dermatitis (0.15% cream) and seborrheic dermatitis (0.3% foam).

Zoryve is a topical phosphodiesterase 4 (PDE4) inhibitor. PDE4 is an intracellular enzyme that drives overactive immune responses in a range of inflammatory diseases.
Approval is supported by the Phase 3 ARRECTOR study and a Phase 2 trial (Trial 204) with 736 patients 12 years and older with mild to severe plaque psoriasis of scalp and body. In each trial, subjects were randomized 2:1 to receive Zoryve foam 0.3% or vehicle foam applied once daily for 8 weeks.
IGA (Investigator Global Assessment) success was defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline. For Scalp-IGA, 66.4% of those using Zoryve foam vs. 27.8% treated with a matching vehicle foam achieved Scalp-IGA Success at Week 8 (P<0.0001). For Body-IGA, 45.5% using Zoryve vs. 20.1% of those treated with vehicle foam achieved Body-IGA Success at Week 8 (P<0.0001).
Trial 204 met its primary endpoint with 56.7% of individuals treated with Zoryve foam achieving S-IGA Success compared to 11% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001). In addition, 39% of individuals treated with Zoryve foam achieved B-IGA Success compared to 7.4% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001).
Zoryve foam is applied to the affected areas once daily. Psoriasis lesions may be difficult to treat with cream or ointments, which can be inconvenient and messy to apply to skin when hair is present.
Do not use Zoryve in patients with moderate to severe liver impairment (Child-Pugh B or C) or in or on the eyes, mouth, or vagina.
Common adverse reactions in patients using Zoryve foam 0.3% for plaque psoriasis of the scalp and body include headache, diarrhea, nausea, and nasopharyngitis (common cold symptoms).
Zoryve (roflumilast) is manufactured by Arcutis.

Fresenius Kabi’s Biosimilar Otulfi Granted Interchangeable Status with Stelara

In May, the FDA designated Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara (ustekinumab). Otulfi is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, to help reduce inflammation, pain, swelling, and skin symptoms. Otulfi was previously approved as a biosimilar to Stelara on September 27, 2024.

A biosimilar is a biological product that is like the reference biologic (in this case Stelara) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.
An interchangeable biosimilar can be dispensed at the pharmacy as a substitute for the reference product (Stelara) without requiring direct approval from the prescribing healthcare provider (based on state pharmacy laws).
Otulfi is approved to treat Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis, which are all autoimmune conditions. It is approved in both subcutaneous and intravenous formulations.
Warnings and precautions with Otulfi include the increased risk of serious infections, an increased risk of malignancy, hypersensitivity (allergic) reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and an increased risk of noninfectious pneumonia.
Common adverse reactions (based on indication) include nasopharyngitis, headache, fatigue, nausea, vomiting, and sinusitis, among several other side effects.
Otulfi is the fourth FDA-approved Stelara biosimilar, following the approvals of Pyzchiva (ustekinumab-ttwe) and Selarsdi (ustekinumab-aekn) in 2024 and Wezlana (ustekinumab-auub) in 2023.

Nuvaxovid (COVID-19 Vaccine, Adjuvanted) Cleared by the FDA to Prevent COVID-19

In May, the FDA approved Nuvaxovid (COVID-19 Vaccine, Adjuvanted), a protein-based, non-MRNA vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older, and for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Nuvaxovid is an updated version of the Novavax COVID-19 Vaccine formulated to target the JN.1 variant. Nuvaxovid is engineered using recombinant nanoparticle technology to create copies of the surface spike protein of SARS-CoV-2, which serve as the antigen.
Approval was based on Phase 3 data that showed Nuvaxovid was safe and effective for the prevention of COVID-19. The FDA has also requested a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.
Nuvaxovid is injected as a single intramuscular dose. For individuals who have been previously vaccinated with any COVID-19 vaccine, Nuvaxovid should be administered at least 2 months after the last dose of COVID-19 vaccine.
Warnings and precautions associated with Nuvaxovid include increased risks of myocarditis and pericarditis (types of heart inflammation).
Common adverse reactions (>10%) include: injection site tenderness or pain, headache, fatigue, muscle pain, malaise, nausea / vomiting, fever, and joint pain.
The Novavax COVID-19 Vaccine has been available for use in the U.S since July 2022 under Emergency Use Authorization (EUA).

FDA Approves Yutrepia, a Prostacyclin Analog Inhalation Powder for Serious Lung Diseases

Yutrepia (treprostinil) is an inhaled dry powder formulation of the prostacyclin mimetic treprostinil approved to improve exercise ability in pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3).

Studies establishing effectiveness in PAH; WHO Group 1 predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
Studies establishing effectiveness in PH-ILD; WHO Group 3 predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

Pulmonary arterial hypertension (PAH) is a rare, long-term disease caused by narrowing, thickening or stiffening of the pulmonary arteries that can lead to right heart failure and eventually death. There is no cure at this time, but existing treatments aim to mitigate symptoms, delay disease progression, and improve quality of life.
Pulmonary hypertension associated with interstitial lung disease (ILD) includes up to 200 pulmonary diseases, including interstitial pulmonary fibrosis, chronic hypersensitivity pneumonitis, and chronic pulmonary fibrosis with emphysema (CPFE) among others. Any level of PH in ILD patients is associated with a poor 3-year survival.
Symptoms of PAH or PH-ILD may include fatigue, shortness of breath, dizziness, chest pressure, fainting, rapid heart rate, swollen stomach, or swelling of legs and ankles.
The approval of Yutrepia is based on findings from the TRIUMPH 1 (PAH, WHO Group 1), INCREASE (PH-ILD, WHO Group 3) and INSPIRE (PAH, WHO Group 1, NYHA Class II/III) clinical trials.

Studies demonstrated that treprostinil inhalation solution increased the change in six-minute walk distance (6MWD) relative to baseline at 12 weeks by 20 meters (~66 feet) in TRIUMPH 1 (p<0.001) and 6MWD relative to baseline at 16 weeks by 21 meters (~69 feet) in INCREASE (p=0.004).
In the Phase 3, open‐label, multicenter INSPIRE trial, 121 patients were enrolled who were naïve to (had not received) treprostinil, as well as those transitioning to Yutrepia inhalation powder from nebulized treprostinil. Eighty percent (in the transition group) and 96% (in the prostacyclin naive group) achieved a dose ≥79.5 mcg four times daily at one year, with one patient achieving a dose of 212 mcg four times a day. Yutrepia was shown to be safe and well-tolerated regardless of a patient’s previous exposure to treprostinil.

The novel inhalation powder in Yutrepia consists of a small, uniform particle size to help with delivery deep into the lungs. It is administered through a convenient, low-effort, palm-sized device 3 to 5 times per day and is available in 4 strengths: 26.5 mcg, 53 mcg, 79.5 mcg, 106 mcg. The contents of each capsule can be inhaled in 2 breaths. Do not swallow the capsules and use only with the provided inhaler.
Warnings and precautions include low blood pressure, increased risk of bleeding, and bronchospasm. Dosage adjustments may be needed with CYP2C8 enzyme inducers or inhibitors.
The most common adverse reactions (≥10%) are cough, headache, throat irritation, and dizziness, which are known side effects of treprostinil inhalation solution. Yutrepia is manufactured by Liquidia Technologies.

FDA Approves Tryptyr Ophthalmic Solution for the Treatment of Dry Eye Disease

This past month the FDA cleared Tryptyr (acoltremon ophthalmic solution, 0.003%), a first-in-class TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). It is thought to work in the treatment of DED by activating trigeminal nerve signaling which leads to increased basal tear production.

Dry Eye Disease (DED) is a common disorder of the ocular surface that occurs when the eyes don't make enough tears to stay lubricated, or when the tears are of poor quality and therefore evaporate too quickly. Symptoms can include burning, itching, stinging, blurred vision, redness, and sensitivity to light.
FDA approval of Tryptyr was supported by two Phase 3 clinical trials (COMET-2 and COMET-3) of more than 930 patients (randomized 1:1 to Tryptyr or vehicle) with a history of DED. In both trials, patients experienced at least a 10 mm increase in natural tear production at Day 14, compared to the vehicle (42.6% versus 8.2% of patients in COMET-2, and 53.2% versus 14.4% of patients in COMET-3 (both p<0.0001)). Patients using Tryptyr demonstrated statistically significant natural tear production as early as Day 1.
Tryptyr is administered as one drop into each eye twice daily. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of the eye drops.
Warnings and Precautions include the potential for eye injury and contamination.
Common adverse reactions include instillation site pain (50%).
Tryptyr is manufactured by Alcon Laboratories.

Posted May 2025

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