January 2024

New Oncology Agents - A Look Back and the Year Ahead

2023 saw 16 new drugs approved for oncology, with targeted therapies and T-cell engaging bispecifics accounting for 12; 5 approvals were accelerated.
There are more new oncology agents in pre-registration already in 2024: 18 new assets and 9 new targets pending before FDA.

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2023's new oncology drugs were primarily targeted therapies for already approved targets and T-cell engagers for liquid tumors

2023 New Oncology Agents

Targeted

Cell/Gene Therapy

Bispecific

ADC

Other

Radiopharm

Approved

Jaypirca (BTK)^AA

Vanflyta (FLT3)

Ojjaara (JAK)

Fruzaqla (VEGF)

Augtyro (ROS1)

Truqap (AKT)

Ogsiveo (γ secretase)

Iwilfin (ODC)

Omisurge (enhanced
CD34+ stem cells)

Zynyz (PD-1)^AA

Loqtorzi (PD-1)

Epkinly (CD20xCD3)^AA

Columvi (CD20xCD3)^AA

Talvey (GPRC5DxCD3)^AA

Elrexfio (BCMAxCD3)^AA

Orserdu (SERD)

Rejected

Hypericin (PDT¹)

ALT-803 (IL-15)

Cosibelimab (PD-L1)

Trastuzumab duocarmazine
(HER2)

Above: Bold - novel target; ^AA - accelerated approval; ¹ - photodynamic therapy

Five new MOAs, including AKTi for HR+ breast cancer (Truqap, Astra Zeneca) and GPRC5D for multiple myeloma (Talvey), strengthening J&J’s presence in myeloma.
After many failures, the first oral SERD was approved for late line ESR1 mutated HR+ breast cancer (Orserdu, Menarini); programs from Astra Zeneca, Eli Lilly, and Roche could enter in earlier lines if Ph3 trials are successful.
6 of 15 drugs received accelerated approval (all but 1 in liquid tumors); with 2023’s FDA guidance on accelerated approval, this proportion is likely to decrease.

2024 appears on track to surpass 2023 in terms of new approvals and MOAs: 18 assets and 9 novel targets in front of FDA

2024 Potential New Oncology Agents

	Targeted	Cell/Gene Therapy	IO	Bispecific	ADC	Radiopharm
Approved
Filed	Rivoceranib (VEGF) Imetelstat (telomerase) Tovorafenib (RAF) Apatinib (VEGF) Axatilimab (CSF1R) Revumenib (menin)	Lifileucel (TILs) Afimi-cel (MAGEA4) Obe-cel (CD19)	Penpulimab (PD-1) Camrelizumab (PD-1) Tislelizumab (PD-1) ALT-803 (IL-15)	Tarlatamab (DLL3xCD3) Odronextamab (CD20xCD3) Zanidatamab (HER2xHER2)¹	Patritumab-DXd (HER3)
Filing Soon?	Vimseltinib (CSF1R)			Zenocutuzumab (HER2xHER3)	Dato-DXd (TROP2) Teliso-V (MET)	Iopofosine Iomab-B (CD45)
Rejected/ Deferred	Zolbetuximab (claudin18.2)

Above: Bold - novel target; ^AA - accelerated approval; ¹ - rolling BLA initiated

First solid tumor cell therapies likely to have niche positioning: AdaptImmune MAGEA4 in rare synovial sarcoma, and Iovance melanoma TILs carries IL-2 requirement.
Tarlatamab (DLL3xCD3, Amgen): first solid tumor T-cell engager for 2L+ SCLC.
Zolbetuximab (claudin18.2, Astellas): new target for gastric cancer showed some OS benefit, but approval is held up by CMC.

Key Questions for 2024

Recent Trends...

...Emerging Questions

T-cell engagers and cell therapies are poised to enter in solid tumors

How will these therapies be adopted in settings where management of CRS or IL-2 is less familiar?

EV+ pembro earns standing ovation at ESMO, while TROP2 marginal in NSCLC – and ADC dealmaking continues

Where do ADCs demonstrate incremental vs. substantial benefit? Which ADC component(s) drive differentiation?

Enhertu filed for pan-tumor approval, including NSCLC and CRC data

How viable are novel IHC companion diagnostics across tumor types? How much impact does marker prevalence have?

Still waiting on SKY1 (TIGIT) – Gilead ups investment in Arcus’ domvanalimab, GSK/iTeos planning Ph3 trials in NSCLC and HNSCC

What is the path forward for IO beyond PD-1? How much impact will neo/adjuvant approvals have on metastatic cases?

Contact Us

Erin Olsen	Michelle Whang	Elia Farah, PhD
Darren Eskow	Monika Trzcinska, PhD	Paul Zhang