The Majority of FDA and EMA Oncology Drug Approvals in Q4 2025 Were for Biologics and Biosimilars

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 54 new or expanded indications for previously approved agents (including 15 denosumab biosimilars) and only 2 new oncology agents in the fourth quarter of 2025. The approvals included approximately 13 solid tumor types and 8 hematologic malignancies. The majority of the approvals were for biologics or biosimilars; there were 15 biosimilar and 25 biologic approvals. There was 1 drug (a biologic) approved by both the FDA and the EMA, cemiplimab-rwlc, (Libtayo^®; Regeneron) for treatment of cutaneous squamous cell carcinoma.

Additional highlights from the fourth quarter of 2025:

Drug approvals encompassed 23 different modes of action; the most common were RANKL inhibitors (15 approvals, all denosumab biosimilars, 12 of which were “interchangeable” designation), PD-1 inhibitors (7 approvals), PD-L1–blocking antibodies (5 approvals), bispecifics (3 approvals), antibody-drug conjugates (3 approvals), and monoclonal antibodies (3 approvals)
The tumor types with the most approvals were lung (7; non-small cell lung cancer [NSCLC] and small cell lung cancer [SCLC]), lymphomas (6; includes follicular, small lymphocytic, mantle cell, and marginal zone lymphomas), bladder cancer (4), breast cancer (3), colorectal cancer (3), and prostate cancer (3)
FDA approvals for solid tumors included
- The first subcutaneous bispecific antibody therapy for EGFR-mutated NSCLC: amivantamab and hyaluronidase-lpuj (Rybrevant Faspro™; Johnson & Johnson)
- A HER2 inhibitor for NSCLC: sevabertinib (Hyrnuo^®; Bayer)
- Lurbinectedin (Zepzelca^®; Jazz Pharmaceuticals), for treatment of SCLC in combination with atezolizumab (Tecentriq^®; Genentech) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza™; Genentech)
- Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig™; Bristol Myers Squibb) for treatment of colorectal cancer following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Rucaparib (Rubraca^®; pharma&) for treatment of prostate cancer
FDA approvals for hematologic malignancies included
- A menin inhibitor for treatment of acute myeloid leukemia: ziftomenib (Komzifti™; Kura Oncology)
- Daratumumab and hyaluronidase-fihj (Darzalex Faspro^®; Johnson & Johnson) for the treatment of light chain amyloidosis
- Pirtobrutinib (Jaypirca^®; Eli Lilly and Company) for treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma
- Retifanlimab-dlwr (Zynyz^®; Incyte) for treatment of Merkel cell carcinoma
The FDA also approved 2 companion diagnostics
- The PATHWAY^® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA^® HER2 Dual ISH DNA Probe Cocktail (Roche) as companion diagnostic devices for selecting patients with HER2-positive (HER2 IHC3+ or ISH+) breast cancer who may be eligible for treatment with fam-trastuzumab deruxtecan-nxki (Enhertu^®; Daiichi Sankyo)
- The Oncomine™ Dx Target Test (Life Technologies Corporation), to aid in detecting HER2 (ERBB2) TKD-activating mutations in patients with nonsquamous NSCLC who may be eligible for treatment with sevabertinib (Hyrnuo^®; Bayer)

The tables below summarize key oncology approvals in Q4 2025. Treatments in bold font represent new agent approvals; all others are biosimilars, indication expansions, or conversion from accelerated to full approval (FDA).

FDA and EMA Approvals

Generic Name

Brand Name

Tumor Type^a

MOA

Manufacturer

Approval

Cemiplimab-rwlc^b

Libtayo^®

Cutaneous SCC

PD-1 inhibitor

Regeneron

10/8/25 (FDA)

October 2025 (EMA)

FDA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA/Drug Class	Manufacturer	Approval
Abiraterone acetate; niraparib tosylate	Akeega^®	Prostate	PARP inhibitor and CYP17 inhibitor	Johnson & Johnson	12/12/25
Amivantamab and hyaluronidase-lpuj^b	Rybrevant Faspro™	NSCLC	Bispecific antibody	Johnson & Johnson	12/17/25
Atezolizumab^b	Tecentriq^®	SCLC	PD-L1–blocking antibody	Genentech	10/2/25
Atezolizumab and hyaluronidase-tqjs^b	Tecentriq Hybreza™	SCLC	PD-L1–blocking antibody and endoglycosidase	Genentech	10/2/25
Atezolizumab and hyaluronidase-tqjs^b	Tecentriq Hybreza	Alveolar soft part sarcoma	PD-L1–blocking antibody and endoglycosidase	Genentech	11/24/25
Belantamab mafodotin-blmf^b	Blenrep	Multiple myeloma	Antibody-drug conjugate	GSK	10/23/25
Daratumumab and hyaluronidase-fihj^b	Darzalex Faspro^®	Multiple myeloma	Monoclonal antibody and polysaccharide	Johnson & Johnson	11/6/25
Daratumumab and hyaluronidase-fihj^b	Darzalex Faspro	Light chain amyloidosis	Monoclonal antibody and polysaccharide	Johnson & Johnson	11/19/25
Denosumab-bnht^c	Bomyntra^®	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Fresenius Kabi	10/29/25
Denosumab-bnht^c	Conexxence^®	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Fresenius Kabi	10/29/25
Denosumab-bmwo^c	Stoboclo^®	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Celltrion	10/29/25
Denosumab-bmwo^c	Osenvelt^®	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Celltrion	10/29/25
Denosumab-desu^d	Jubereq	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Accord BioPharma	10/29/25
Denosumab-desu^d	Osvyrti	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Accord BioPharma	10/29/25
Denosumab-dssb^c	Ospomyv™	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Samsung Bioepis	10/29/25
Denosumab-dssb^c	Xbryk™	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Samsung Bioepis	10/29/25
Denosumab-kyqq^c	Bosaya™	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Biocon Biologics	10/29/25
Denosumab-kyqq^c	Aukelso™	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Biocon Biologics	10/29/25
Denosumab-mobz^d	Oziltus	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Amneal Pharmaceuticals	12/19/25
Denosumab-nxxp^c	Bildyos^®	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Shanghai Henlius	10/29/25
Denosumab-nxxp^c	Bilprevda^®	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Shanghai Henlius	10/29/25
Denosumab-qbde^c	Enoby™	To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture	RANKL inhibitor	Hikma Pharmaceuticals	10/29/25
Denosumab-qbde^c	Xtrenbo	Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy	RANKL inhibitor	Hikma Pharmaceuticals	10/29/25
Durvalumab^b	Imfinzi^®	Gastric, GEJ	PD-L1–blocking antibody	AstraZeneca	11/25/25
Enfortumab vedotin-efjv^b	Padcev^®	Bladder	Antibody-drug conjugate	Astellas Pharma	11/21/25
Epcoritamab	Epkinly^®	Follicular lymphoma	Bispecific antibody	Genmab	11/18/25
Fam-trastuzumab deruxtecan-nxki^b	Enhertu^®	Breast	Antibody-drug conjugate	Daiichi Sankyo	12/15/25
Lisocabtagene maraleucel^b	Breyanzi™	Marginal zone lymphoma	CAR T	Bristol Myers Squibb	12/4/25
Lurbinectedin	Zepzelca^®	SCLC	Alkylating drug	Jazz Pharmaceuticals	10/2/25
Mosunetuzumab-axgb^b	Lunsumio Velo™	Follicular lymphoma	Bispecific antibody	Genentech	12/19/25^e
Nivolumab and hyaluronidase-nvhy^b	Opdivo Qvantig™	Colorectal (following treatment with IV nivolumab and ipilimumab)	PD-1 inhibitor and endoglycosidase	Bristol Myers Squibb	10/27/25
Nivolumab and hyaluronidase-nvhy^b	Opdivo Qvantig™	Colorectal (following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan)	PD-1 inhibitor and endoglycosidase	Bristol Myers Squibb	10/27/25
Nivolumab and hyaluronidase-nvhy^b	Opdivo Qvantig™	Colorectal (pediatric ≥12 years)	PD-1 inhibitor and endoglycosidase	Bristol Myers Squibb	11/24/25
Pegfilgrastime-unne^d	Armlupeg	Infections	G-CSF	Lupin	11/28/25
Pembrolizumab^b	Keytruda^®	Bladder	PD-1 inhibitor	Merck	11/21/25
Pembrolizumab and berahyaluronidase alfa-pmph^b	Keytruda Qlex™	Bladder	PD-1 inhibitor and endoglycosidase	Merck	11/21/25
Pemetrexed	Axtle™	NSCLC	Folate analog metabolic inhibitor	Avyxa Holdings	10/3/25
Pertuzumab-dpzb^c	Poherdy^®	Breast	HER2/neu receptor antagonist	Shanghai Henlius	11/13/25
Pirtobrutinib	Jaypirca^®	CLL or SLL	BTK inhibitor	Eli Lilly and Company	12/2/25
Retifanlimab-dlwr^b	Zynyz^®	Merkel cell carcinoma	PD-1 inhibitor	Incyte	12/17/25
Revumenib	Refuforj^®	AML	Menin inhibitor	Syndax	10/24/25
Rucaparib	Rubraca^®	Prostate	PARP inhibitor	pharma&	12/17/25
Selumetinib	Koselugo^®	Neurofibromatosis	MEK inhibitor	AstraZeneca	11/19/25
Sevabertinib	Hyrnuo^®	NSCLC	HER2 inhibitor	Bayer	11/19/25
Ziftomenib	Komzifti™	AML	Menin inhibitor	Kura Oncology	11/13/25

EMA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA/Drug Class	Manufacturer	Positive Opinion
Asciminib	Scemblix^®	CML	TKI	Novartis	October 2025
Enzalutamide	Enzalutamide	Prostate	Androgen receptor inhibitor	Accord Healthcare	November 2025
Imlunestrant	Inluriyo™	Breast	ER antagonist	Eli Lilly	November 2025
Lisocabtagene maraleucel^b	Breyanzi™	Mantle cell lymphoma	CAR T	Bristol Myers Squibb	October 2025
Nogapendekin alfa inbakicept^b	Anktiva^®	Bladder	IL-15 receptor agonist	Serum Life Science Europe	December 2025
Selumetinib	Koselugo^®	Plexiform neurofibroma (pediatric)	MEK inhibitor	AstraZeneca	November 2025
Sugemalimab^b	Cejemly^®	NSCLC	PD-L1– blocking antibody	CStone Pharmaceuticals	October 2025
Tafasitamab^b	Minjuvi^®	Follicular lymphoma	Monoclonal antibody	Incyte	November 2025

a Please see each product’s prescribing information and summary of product characteristics for full indications and labeling information.
b Biologic.
c Interchangeable biosimilar.
d Biosimilar.
e Accelerated approval.

AML, acute myeloid leukemia; BTK, Bruton tyrosine kinase inhibitor; CAR T, chimeric antigen receptor T-cell therapy; CLL, chronic lymphocytic leukemia; CML, chronic myeloid leukemia; CYP17A1, cytochrome P450 family 17 subfamily A member 1; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; ER, estrogen receptor; ERBB2, epidermal growth factor receptor 2 (HER2); FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; HER2, human epidermal growth factor receptor 2; IL-15, interleukin-15; MEK, Mitogen-activated protein kinase; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PARP, poly(ADP-ribose) polymerase; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; RANKL, receptor activator of nuclear factor kappa-beta ligand; SCC, squamous cell carcinoma; SCLC, small cell lung cancer; SLL, small lymphocytic lymphoma; TKI, tyrosine kinase inhibitor.

Sources:

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-october-2025

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-november-2025

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-december-2025

https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for/

Matthew Gordon

VP, Real-World Evidence

Matthew has more than 25 years of experience in real-world evidence and observational, non-interventional research. He has led studies across the full life cycle—from startup through publication—supporting objectives that range from understanding a disease’s natural history to fulfilling global safety surveillance requirements. Matthew brings deep expertise in orphan disease programs, having overseen more than 25 long-term, global initiatives, as well as in disease and product registries, prospective pharmacoeconomic studies, and systematic literature reviews. Matthew leads the RWE Registries team, responsible for building the business and team. Prior to joining Aptitude Health, he held senior leadership roles at Parexel, Worldwide Clinical Trials, inVentiv Health Clinical, Quintiles Outcome, and ICON Clinical Research. Matthew holds a BA in sociology from Boston University, is a long-standing member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and is a frequent speaker at ISPOR, the Center for Business Intelligence, and related industry conferences.

Gerald Stanvitch, PhD

VP, Scientific Content

Cate Browning, PhD

VP, Global Medical Affairs

Erin Zingales Rau

VP, Account Services

Kelly Kocor

VP, People & Culture

Kelly leads both the human resources and talent acquisition teams, ensuring that Aptitude Health attracts, retains, and develops top personnel to drive our continued success. With over 17 years of experience transforming global HR initiatives, Kelly is an expert in harmonizing HR policies and fostering a culture of engagement and partnership. She is committed to partnering with all areas of the business to ensure full regulatory compliance and delivering value-added services to our organization and its people. Kelly is passionate about developing and implementing HR strategies that help support our employees’ professional and personal growth. She is dedicated to fostering a culture that encourages innovation, collaboration, and inclusivity, helping Aptitude Health continue to be a great place to work.

Bart Zygmond

VP, Finance

Bart brings a wealth of experience to the organization, having worked in the life sciences, pharmaceuticals, manufacturing, and service industries. With his expertise in financial reporting, US GAAP, SOX, cash flow modeling, and financial analysis, he plays a crucial role in the company’s financial management and strategy. Prior to joining Aptitude Health as VP, Finance, Bart held several controller positions: at Q2 Solutions, he oversaw the global finance team and financial operations, ensuring the accurate and timely financial reporting of the company. He also held controller positions at Domtar Inc and Veristat.

Eugene Vissers, MD

Senior VP, Global Scientific Content

Eugene is a seasoned medical doctor with over 20 years of international experience in pharma, consultancy, and agency environments. Eugene leads the US team of dedicated experts responsible for developing high-quality medical content. Prior to joining Aptitude Health, Eugene served as medical director at Ipsen and AstraZeneca. With both his medical degree and an MBA, Eugene brings a unique perspective to his role. His clinical background, combined with his business acumen, allows him to develop innovative strategies that drive results. Under Eugene’s leadership, the medical content team delivers scientific information of the highest quality, providing valuable insights to our clients around the world.

Adrian Barfield

VP, US Business Development

Kelley Hernandez

Executive VP, US Business Development

Kelley has over 18 years of experience in the oncology space. Kelley joined Aptitude Health after working with Cardinal Health, where she was part of the Healthcare and Analytics Division, and finished her tenure there with VitalSource™ (GPO division). As the leader of the strategic business development team for the US, Kelley brings a wealth of expertise to the organization. Her experience in the healthcare industry, combined with her ability to identify and capitalize on new business opportunities, is invaluable in driving the company’s growth and success. Kelley’s dedication to building strong relationships with life science partners is a testament to her commitment to delivering exceptional value to the healthcare industry.

Adam Sinensky, MBA

Chief Technology Officer

Adam has over 20 years of experience in the healthcare industry and an MBA in healthcare management. After 10 years as a strategy consultant to life science companies, Adam has spent the last decade as a product and strategy leader focused on bringing technology products to market across the payor, provider, and life sciences segments. By combining his business acumen and experience working directly with software developers, engineers, and data scientists, Adam has successfully led numerous product launches and enhancements from ideation to development and go-to-market initiatives. His product and change management expertise has led organizational shifts from services to technology at companies such as Change Healthcare and Datavant/Ciox. At Aptitude Health, Adam is responsible for growing our portfolio of product offerings by leveraging real-world data and artificial intelligence with our existing solutions and industry-leading Axess Network of healthcare providers. He also oversees our IT and cybersecurity teams.

Stefanie Daniels

Chief Commercial Officer

Stefanie is a seasoned healthcare executive with over 20 years of experience in oncology. She brings a wealth of knowledge and expertise to the organization. Stefanie joined Aptitude Health after spending over a decade as a senior director at Physicians’ Education Resource, an oncology CME vendor. During her tenure, she led and managed teams responsible for grant development/acquisition, program creation/execution, and faculty management. Stefanie’s deep understanding of the oncology industry and her ability to lead teams through complex projects make her a vital part of the organization’s success. Her dedication to providing high-quality solutions to our life science partners is a testament to her commitment to improving cancer patient care.

Jason Cash

Chief Financial Officer

Jason is an accomplished finance professional with over 20 years of experience in the pharmaceutical services industry. Throughout his career, he has demonstrated a keen ability to navigate high-growth organizations, delivering exceptional results. Before joining Aptitude Health, Jason served as the CFO of Veristat International, a global contract research organization. In this role, he led the financial strategy and played a pivotal role in driving the company’s growth and success. Jason’s wealth of experience and expertise in financial management make him an essential member of the leadership team. His strategic thinking and ability to drive results are highly respected within the industry.

Jez Moulding

Chief Executive Officer

Jez is a seasoned leader with over 20 years of experience in general management and regional president roles. He has a proven track record of success in the healthcare industry, having worked in the US, Japan, Australia, Korea, South Africa, France, and the UK for Sanofi, where he supported the launch of 10 new drugs across various therapeutic areas. As chief commercial officer at UDG Healthcare and EVP at Ashfield, Jez demonstrated his expertise in developing and implementing successful business strategies. He joined Aptitude Health from Pharmaspectra, an IQVIA business, where he served as CEO since 2018. Jez’s extensive experience in the pharmaceutical industry and his leadership skills make him an invaluable asset to the organization.

News & Events

The Majority of FDA and EMA Oncology Drug Approvals in Q4 2025 Were for Biologics and Biosimilars

FDA Approvals

Generic Name

Brand Name

Tumor Typea

MOA/Drug Class

Manufacturer

Approval

Abiraterone acetate; niraparib tosylate

Akeega®

Prostate

PARP inhibitor and CYP17 inhibitor

Johnson & Johnson

12/12/25

Amivantamab and hyaluronidase-lpujb

Rybrevant Faspro™

NSCLC

Bispecific antibody

Johnson & Johnson

12/17/25

Atezolizumabb

Tecentriq®

SCLC

PD-L1–blocking antibody

Genentech

10/2/25

Atezolizumab and hyaluronidase-tqjsb

Tecentriq Hybreza™

SCLC

PD-L1–blocking antibody and endoglycosidase

Genentech

10/2/25

Atezolizumab and hyaluronidase-tqjsb

Tecentriq Hybreza

Alveolar soft part sarcoma

PD-L1–blocking antibody and endoglycosidase

Genentech

11/24/25

Belantamab mafodotin-blmfb

Blenrep

Multiple myeloma

Antibody-drug conjugate

GSK

10/23/25

Daratumumab and hyaluronidase-fihjb

Darzalex Faspro®

Multiple myeloma

Monoclonal antibody and polysaccharide

Johnson & Johnson

11/6/25

Daratumumab and hyaluronidase-fihjb

Darzalex Faspro

Light chain amyloidosis

Monoclonal antibody and polysaccharide

Johnson & Johnson

11/19/25

Denosumab-bnhtc

Bomyntra®

Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy

RANKL inhibitor

Fresenius Kabi

10/29/25

Denosumab-bnhtc

Conexxence®

To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture

RANKL inhibitor

Fresenius Kabi

10/29/25

Denosumab-bmwoc

Stoboclo®

To increase bone mass in men with prostate cancer at high risk for fracture and in women with breast cancer at high risk for fracture

RANKL inhibitor

Celltrion

10/29/25

Denosumab-bmwoc

Osenvelt®

Prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy

RANKL inhibitor

Celltrion

Tumor Type^a

Akeega^®

Amivantamab and hyaluronidase-lpuj^b

Atezolizumab^b

Tecentriq^®

Atezolizumab and hyaluronidase-tqjs^b

Atezolizumab and hyaluronidase-tqjs^b

Belantamab mafodotin-blmf^b

Daratumumab and hyaluronidase-fihj^b

Darzalex Faspro^®

Daratumumab and hyaluronidase-fihj^b

Denosumab-bnht^c

Bomyntra^®

Denosumab-bnht^c

Conexxence^®

Denosumab-bmwo^c

Stoboclo^®

Denosumab-bmwo^c

Osenvelt^®

Denosumab-desu^d

Denosumab-desu^d

Denosumab-dssb^c

Denosumab-dssb^c

Denosumab-kyqq^c

Denosumab-kyqq^c

Denosumab-mobz^d

Denosumab-nxxp^c

Bildyos^®

Denosumab-nxxp^c

Bilprevda^®

Denosumab-qbde^c

Denosumab-qbde^c

Durvalumab^b

Imfinzi^®