FDA Approves Merck’s KEYTRUDA QLEX for Subcutaneous Use Across Multiple Solid Tumors

Merck announced that the FDA has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous administration in adults across most of KEYTRUDA’s approved solid tumor indications. Unlike the intravenous (IV) formulation, KEYTRUDA QLEX can be administered by a healthcare provider in as little as one minute, offering patients a faster and more flexible treatment option.

“This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers. We now have a new option with a broad set of indications that has demonstrated comparability with IV pembrolizumab but in a subcutaneous injection that can be administered in one minute every three weeks or two minutes every six weeks,” said Dr. J. Thaddeus Beck, oncologist and Medical Director of the Highlands’ Clinical Trials Office.

The FDA decision was supported by a pivotal trial in treatment-naïve metastatic non-small cell lung cancer (NSCLC) patients, which compared subcutaneous KEYTRUDA QLEX to IV KEYTRUDA. Results showed similar pharmacokinetics, safety, and efficacy outcomes, with overall response rates of 45% versus 42%, respectively, and no notable differences in progression-free or overall survival.

“At Merck, we are committed to putting patients first, as we work relentlessly to discover new options that may help patients manage their treatment in a way that fits their needs,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We are honored to build on the foundation of KEYTRUDA with KEYTRUDA QLEX, a new injectable immunotherapy option that has similar results to KEYTRUDA and can be administered in as little as one minute.”

Merck expects KEYTRUDA QLEX to be available in the U.S. in late September, providing patients and physicians with a convenient alternative to IV infusions and expanding treatment access across multiple care settings.

Incyte Secures FDA Nod for OPZELURA Cream in Children (2–11) With Atopic Dermatitis

Incyte announced that the FDA has approved OPZELURA (ruxolitinib) cream 1.5% for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children aged two years and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

“With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option with the potential to significantly improve the burdensome symptoms they experience every day,” said Bill Meury, Chief Executive Officer, Incyte.

The decision was supported by positive results from the phase III TRuE-AD3 trial, which evaluated ruxolitinib cream in children aged ≥2 to <12 years with AD. The study met its primary endpoint, with significantly more patients achieving Investigator’s Global Assessment-treatment success (IGA-TS) compared to vehicle control, alongside secondary endpoints including EASI75 response at Week 8. The safety profile was consistent with earlier studies, with no new safety signals observed.

“Children with atopic dermatitis currently have limited treatment options to meet their specific needs,” said Dr. Peter Lio, Clinical Assistant Professor of Dermatology & Pediatrics at Northwestern University Feinberg School of Medicine. “With this approval, we now have a new, non-steroidal topical option that expands how we care for kids with this chronic disease.”

Minovia Therapeutics Gets FDA Fast Track for MNV-201 in Myelodysplastic Syndrome

Minovia Therapeutics Ltd., a clinical-stage biotechnology company developing mitochondrial-targeted therapies, announced that the FDA has granted Fast Track Designation (FTD) to its lead investigational compound, MNV-201, for the treatment of myelodysplastic syndrome (MDS), a serious hematopoietic disease associated with aging.

“The Fast Track Designation in MDS is further validation of the urgency and potential for our science, which targets the mitochondria, a critical multi-functional organelle,” said Natalie Yivgi-Ohana, Ph.D., Co-founder and CEO of Minovia. “FDA designations such as the FTD help us decrease the potential time to market and provide additional benefits across the FDA process that, we expect, will prove both medically and financially valuable.”

MNV-201 already holds Fast Track and Rare Pediatric Disease Designations for Pearson Syndrome, an ultra-rare mitochondrial disorder affecting children, for which Minovia is currently conducting a phase II clinical trial. The new designation broadens the potential of the therapy across both rare pediatric and age-related diseases.

In parallel, Minovia has entered into a definitive business combination agreement with Launch One Acquisition Corp. (Nasdaq: LPAA), a SPAC. Upon closing of the transaction, expected in late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

MavriX Bio Awarded FDA Fast Track for MVX-220 Gene Therapy in Angelman Syndrome

MavriX Bio announced that the FDA has granted Fast Track designation to MVX-220, its investigational AAV-based gene therapy for the treatment of Angelman syndrome (AS). The designation underscores the urgent need for innovative therapies in this rare neurological disorder.

“The FDA’s decision reflects the urgent need for therapies for individuals living with Angelman syndrome,” said Allyson Berent, DVM, DACVIM, Chief Development Officer of MavriX Bio. “This designation highlights the promise MVX-220 holds and enables closer collaboration with the FDA and an accelerated path forward.”

In May 2025, MavriX received IND clearance for MVX-220 and is preparing to launch ASCEND-AS, a phase I/II first-in-human study. The company aims to evaluate the safety and potential efficacy of the therapy in patients with Angelman syndrome.

“Fast Track status gives this program crucial momentum,” said James M. Wilson, MD, PhD, CEO of GEMMA Biotherapeutics (GEMMABio), whose team developed MVX-220. “For the Angelman community, it opens a path toward bringing gene-targeted therapies to patients sooner.”

Biocon Biologics Gains FDA Approval for Denosumab Biosimilars BOSAYA and AUKELSO

Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., announced that the FDA has approved BOSAYA (denosumab-kyqq) 60 mg/mL injection and AUKELSO (denosumab-kyqq) 120 mg/1.7 mL injection, biosimilars to PROLIA and XGEVA, respectively. Both medicines also received provisional interchangeability designation, a milestone that expands treatment options for patients with osteoporosis and those undergoing oncology care.

“The FDA’s approval of BOSAYA and AUKELSO is a significant milestone in our mission to expand access to critical biologic therapies,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics. “With BOSAYA™, we are proud to offer a more affordable treatment for osteoporosis, and with AUKELSO™, we are expanding our oncology portfolio, underscoring our commitment to sustainable healthcare systems and better patient outcomes.”

BOSAYA is approved for multiple indications, including postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in patients receiving cancer therapies. AUKELSO is indicated for the prevention of skeletal-related events in multiple myeloma and solid tumor bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy refractory to bisphosphonates. Both biosimilars demonstrated comparable quality, safety, and efficacy to their reference products in clinical evaluations.

According to IQVIA data, denosumab generated nearly $5 billion in U.S. sales in 2024, with PROLIA accounting for $3.3 billion and XGEVA $1.6 billion. With these approvals, Biocon Biologics positions itself as a key player in delivering high-quality, cost-effective biologics to address the growing needs of patients.