The Majority of New FDA and EMA Oncology Drug Approvals in Q4 2024 Were for Biologics and Biosimilars

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved 28 new or expanded indications for previously approved agents and 10 new oncology agents in the last quarter of 2024. The approvals included approximately 34 solid tumor types and 10 hematologic malignancies. More than two-thirds of the approvals were for biologics or biosimilars; there were 20 biologics and 2 biosimilars approved, 7 of which were new agents. One biologic treatment was approved by both the FDA and the EMA for a new indication: tislelizumab (Tevimbra^®; BeiGene), a programmed death-ligand 1 (PD-L1)-blocking antibody approved for treatment of human epidermal growth factor receptor 2 (HER2)-negative gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

Additional highlights from the fourth quarter of 2024

The first medicine to treat von Hippel-Lindau disease, a rare genetic disorder causing cysts and tumors, was approved in Europe: belzutifan (Welireg^™; Merck Sharp & Dohme), a hypoxia-inducible factor 2 alpha (HIF-2ɑ) inhibitor
The first oral formulation of imatinib (Imkeldi; Shorla Oncology) received FDA approval
The FDA approved a new formulation of nilotinib (Danziten^™; Azurity) that is the first approved nilotinib formulation that does not require mealtime restrictions
Non-small cell lung cancer (NSCLC) agents represent the highest number of approvals (7), followed by acute leukemia (5) and breast cancer (4)
Two products that previously received accelerated approval gained full approval by the FDA
- Abemaciclib (Verzenio^®; Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of patients with advanced or metastatic breast cancer
- Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo^®; Genentech) for treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer
The most common molecular targets were programmed cell death protein 1 (PD-1; 5 approvals) and PD-L1 (4 approvals)
There were 5 bispecific antibody approvals
Five companion diagnostics were approved by the FDA
- FoundationOne^®Liquid CDx (Foundation Medicine), a companion diagnostic for inavolisib, to identify patients with hormone receptor-positive, HER2-negative breast cancer with a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation
- VENTANA^® Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody Assay (Ventana Medical Systems, Inc/Roche Diagnostics), a companion diagnostic for zanidatamab-hrii (Ziihera^®; Jazz Pharmaceuticals) to identify patients with HER2-positive, immunohistochemistry (IHC) 3-positive biliary tract cancer
- VENTANA CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc/Roche Diagnostics), a companion diagnostic for treatment with zolbetuximab-clzb (Vyloy^®; Astellas Pharma) to identify patients with HER2-negative gastric or GEJ adenocarcinoma whose tumors are claudin 18.2 positive
- Ion Torrent™ Oncomine™ Dx Target Test (Thermo Fisher Scientific), a companion diagnostic for vorasidenib (Voranigo^®; Servier Pharmaceuticals), to determine isocitrate dehydrogenase mutation status in patients with glioma
- MI Cancer Seek™ (Caris Life Sciences), a companion diagnostic to identify patients who may benefit from treatment with targeted therapies for breast cancer, colorectal cancer, melanoma, NSCLC, solid tumors, or endometrial carcinoma
Two wearable devices received FDA approval
- Optune Lua^® (Novocure; approved October 15), a first-of-its-kind wearable device for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in patients with metastatic NSCLC
  - Delivers Tumor Treating Fields (TTFields), which exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death
- On November 21, 2024, FDA approved new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio^® (Novocure), another wearable portable device that produces TTFields, for treatment of glioblastoma multiforme
  - Patients will be converted from Optune Gio to the new HFE arrays through the first half of 2025 through a controlled transition plan
- Two noteworthy FDA approvals of generics include the first generic paclitaxel (Sandoz) and generic pazopanib

The tables below summarize key Q4 2024 oncology approvals. Treatments in bold font represent new agent approvals by each agency; all others are indication expansions or conversion from accelerated to full approval (FDA).

FDA and EMA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA	Manufacturer	Approval
Tislelizumab^b	Tevimbra^®	Gastric or GEJ adenocarcinoma	PD-L1 inhibitor	BeiGene	12/26/24 (FDA)/October 2024^c(EMA)

FDA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA	Manufacturer	Approval
Abemaciclib	Verzenio^®	Breast	CDK4/6 inhibitor	Eli Lilly and Company	11/13/24
Asciminib	Scemblix^®	Ph+ CML (chronic phase)	ABL/BCR-ABL1 inhibitor	Novartis	10/29/24^d
Cosibelimab-ipdl^b	Unloxcyt™	CSCC	PD-L1 inhibitor	Checkpoint Therapeutics	12/13/24
Durvalumab^b	Imfinzi^®	Limited-stage SCLC	PD-L1 inhibitor	AstraZeneca	12/4/24
Encorafenib	Braftovi^®	Colorectal	BRAF inhibitor	Array BioPharma	12/20/24^d
Ensartinib	Ensacove™	NSCLC	ALK inhibitor	Xcovery Holdings	12/18/24
Filgrastim^b	Zarxio^®	For patients acutely exposed to myelosuppressive doses of radiation	G-CSF	Sandoz	10/22/24
Imatinib	Imkeldi	CML, ALL, MDS/ myeloproliferative disease, GIST	TKI	Shorla Oncology	11/22/24
Inavolisib	Itovebi™	Breast	PI3K inhibitor	Genentech	10/10/24
Methotrexate	Jylamvo™	ALL	Antimetabolite	Shorla Oncology	10/28/24
Nilotinib	Danziten™	Ph+ CML	TKI	Azurity	11/7/24
Nivolumab^b	Opdivo^®	NSCLC (combination, then monotherapy)	PD-1 inhibitor	Bristol Myers Squibb	10/3/24
Nivolumab and hyaluronidase-nvhy^b	Opdivo Qvantig™	Multiple solid tumors	PD-1 inhibitor	Bristol Myers Squibb	12/27/24
Obecabtagene autoleucel^b	Aucatzyl^®	ALL	CAR T-cell therapy	Autolus	11/8/24
Pertuzumab, trastuzumab, and hyaluronidase-zzxf^b	Phesgo^®	Breast	Monoclonal antibodies and endoglycosidase	Genentech	11/22/24
Revumenib	Revuforj^®	*Acute leukemia with KMT2A* translocation**	Menin inhibitor	Syndax	11/15/24
Zanidatamab-hrii^b	Ziihera^®	Biliary tract	HER2-directed bispecific antibody	Jazz Pharmaceuticals	11/20/24^d
Zeno cutuzumab-zbco^b	Bizengri^®	NSCLC and pancreatic adenocarcinoma	HER2- and HER3-directed bispecific antibody	Merus N.V.	12/4/24^d
Zolbetuximab-clzb^b	Vyloy^®	Gastric or GEJ adenocarcinoma	Claudin 18.2-directed cytolytic antibody	Astellas Pharma	4/25/24

EMA Approvals
Generic Name	Brand Name	Tumor Type^a	MOA	Manufacturer	Approval
Amivantamab-vmjw^b	Rybrevant^®	NSCLC	Bispecific antibody	Janssen-Cilag	November 2024^c
Belzutifan^b	Welireg^™	von Hippel-Lindau disease-related tumors and clear cell RCC	HIF-2ɑ inhibitor	Merck Sharp & Dohme	December 2024^e
Blinatumomab^b	Blincyto^®	ALL	Bispecific antibody	Amgen Europe	December 2024^c
Catumaxomab^b	Korjuny^®	Malignant ascites	Bispecific antibody	Lindis Biotech	October 2024^c
Denosumab^f	Osenvelt^®	Advanced cancer involving bone and giant cell bone tumor	RANKL-targeted monoclonal antibody	Celltrion Healthcare	December 2024^c
Denosumab^f	Xbryk	Advanced cancer involving bone and giant cell bone tumor	RANKL-targeted monoclonal antibody	Samsung Bioepis	November 2024^c
Dostarlimab-gxly^b	Jemperli	Endometrial	PD-1 inhibitor	GlaxoSmithKline (Ireland)	December 2024^c
Filgrastim^f	Zefylti	Neutropenia and mobilization of peripheral blood progenitor cells	G-CSF	CuraTeQ Biologics	December 2024^c
Ipilimumab^b	Yervoy^®	Colorectal	CTLA-4 inhibitor	Bristol Myers Squibb	November 2024^c
Isatuximab-irfc^b	Sarclisa^®	Multiple myeloma (combination)	Anti-CD38 monoclonal antibody	Sanofi Winthrop Industrie	November 2024^c
Lazertinib	Lazcluze^®	NSCLC	EGFR TKI	Janssen-Cilag	November 2024^c
Nivolumab^b	Opdivo^®	Colorectal	PD-1 inhibitor	Bristol Myers Squibb	November 2024^c
Osimertinib	Tagrisso^®	NSCLC	EGFR TKI	AstraZeneca	November 2024^c
Pembrolizumab^b	Keytruda^®	Mesothelioma	PD-1 inhibitor	Merck Sharp & Dohme	November 2024^c
Repotrectinib	Augtyro™	ROS1+ advanced solid tumors or NSCLC; solid tumors	ROS1 and TRK inhibitor	Bristol Myers Squibb	November 2024^e
Ribociclib^b	Kisqali^®	Early breast cancer	CDK4/6 inhibitor	Novartis	October 2024^c
Tislelizumab^b	Tevimbra^®	Esophageal squamous cell carcinoma	PD-L1 inhibitor	BeiGene	October 2024^c
^aPlease see each product’s prescribing information and summary of product characteristics for full indications and labeling information. ^bBiologic. ^cPositive opinion. ^dAccelerated approval. ^eConditional marketing authorization. ^fBiosimilar. ABL/BCR-ABL1, breakthrough cluster region/ABL proto-oncogene 1; ALK, anaplastic lymphoma kinase; ALL, acute lymphocytic leukemia; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CAR, chimeric antigen receptor; CDK4/6, cyclin-dependent kinase 4/6; CML, chronic myeloid leukemia; CSCC, cutaneous squamous cell carcinoma; CTLA-4, cytotoxic T-lymphocyte-associated antigen 4; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; FDA, US Food and Drug Administration; G-CSF, granulocyte colony-stimulating factor; GEJ, gastroesophageal junction; GIST, gastrointestinal stromal tumor; HER2, human epidermal growth factor receptor 2; HIF-2ɑ, hypoxia-inducible factor 2 alpha; KMT2A, lysine methyltransferase 2A; MDS, myelodysplastic syndromes; MOA, mechanism of action; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; Ph, Philadelphia chromosome; PI3K, phosphoinositide 3-kinase; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; RANKL, receptor activator of nuclear factor kappa beta; RCC, renal cell carcinoma; ROS1, ROS proto-oncogene 1; SCLC, small cell lung cancer; TKI, tyrosine kinase inhibitor; TRK, tropomyosin receptor kinase.

Sources:

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

https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights

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

https://www.novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer/

https://newsroom.thermofisher.com/newsroom/press-releases/press-release-details/2024/FDA-Approves-NGS-Based-Companion-Diagnostic-for-First-Targeted-Therapy-for-Patients-with-Grade-2-IDH-Mutant-Glioma/default.aspx

https://www.novocure.com/fda-approves-novocures-innovative-hfe-transducer-arrays-for-use-with-optune-gio-for-glioblastoma/

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 & Resources

The Majority of New FDA and EMA Oncology Drug Approvals in Q4 2024 Were for Biologics and Biosimilars

FDA and EMA Approvals

Generic Name

Brand Name

Tumor Typea

MOA

Manufacturer

Approval

Tislelizumabb

Tevimbra®

Gastric or GEJ adenocarcinoma

PD-L1 inhibitor

BeiGene

12/26/24 (FDA)/October 2024c (EMA)

FDA Approvals

Generic Name

Brand Name

Tumor Typea

MOA

Manufacturer

Approval

Abemaciclib

Verzenio®

Breast

CDK4/6 inhibitor

Eli Lilly and Company

11/13/24

Asciminib

Scemblix®

Ph+ CML (chronic phase)

ABL/BCR-ABL1 inhibitor

Novartis

10/29/24d

Cosibelimab-ipdlb

Unloxcyt™

CSCC

PD-L1 inhibitor

Checkpoint Therapeutics

12/13/24

Durvalumabb

Imfinzi®

Limited-stage SCLC

PD-L1 inhibitor

AstraZeneca

12/4/24

Encorafenib

Braftovi®

Colorectal

BRAF inhibitor

Array BioPharma

12/20/24d

Ensartinib

Ensacove™

NSCLC

ALK inhibitor

Xcovery Holdings

12/18/24

Filgrastimb

Zarxio®

For patients acutely exposed to myelosuppressive doses of radiation

G-CSF

Sandoz

10/22/24

Imatinib

Imkeldi

CML, ALL, MDS/ myeloproliferative disease, GIST

TKI

Shorla Oncology

11/22/24

Inavolisib

Itovebi™

Breast

PI3K inhibitor

Genentech

10/10/24

Methotrexate

Jylamvo™

ALL

Antimetabolite

Tumor Type^a

Tislelizumab^b

Tevimbra^®

12/26/24 (FDA)/October 2024^c(EMA)

Tumor Type^a

Verzenio^®

Scemblix^®

10/29/24^d

Cosibelimab-ipdl^b

Durvalumab^b

Imfinzi^®

Braftovi^®

12/20/24^d

Filgrastim^b

Zarxio^®

CML, ALL, MDS/
myeloproliferative disease, GIST

Nivolumab^b

Opdivo^®

Nivolumab and hyaluronidase-nvhy^b

Obecabtagene autoleucel^b

Aucatzyl^®

Pertuzumab, trastuzumab,
and hyaluronidase-zzxf^b

Phesgo^®

Revuforj^®

**Acute leukemia with KMT2A translocation**

Zanidatamab-hrii^b

Ziihera^®

11/20/24^d

Zeno
cutuzumab-zbco^b

Bizengri^®

12/4/24^d

Zolbetuximab-clzb^b

Vyloy^®

Tumor Type^a

Amivantamab-vmjw^b

Rybrevant^®

November 2024^c

Belzutifan^b