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FDA Approved Oncology Drugs 2023

FDA Approved Oncology Drugs 2023

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

However, although 55 new drugs is a significant amount, it is relatively small considering the staggering nine out of ten drug candidates that fail during clinical trials and drug approval. That's not to mention the drug candidates that don't advance through discovery and the preclinical stage, which brings the overall rate of failure for drug discovery and development to over 90%.

Drug Discovery and Development: Stages, Failure Rates, and Improvement Strategies

Figure. 1: Overview of drug discovery and development stages and their failure rates. [Adapted from: Sun D, Gao W, Hu H, Zhou S. Why 90% of clinical drug development fails and how to improve it? Acta Pharm Sin B. 2022 Jul;12(7):3049-3062

Over the years, R&D scientists have implemented many successful strategies to improve each drug discovery and development stage. Yet, the overall success rate of clinical drug development still needs to improve. But why do most drugs fail?

Despite promising preclinical data, most drugs fail in clinical development for two main reasons:

  • Poor clinical efficacy
  • Unmanageable toxicity

Initial research, screening, and preclinical trials involving lab-based in vitro and in vivo testing determine which drugs are safe and effective enough to take forward. Thus, the key to success in clinical drug development lies in these early stages: target identification and validation, drug candidate selection and optimization, and the careful balance of clinical dose, efficacy, and toxicity.

For example, good target identification and validation can increase confidence in the relationship between the target, disease, and normal tissue, as well as explore target engagement and determine whether target modulation will lead to mechanism-based side effects. In addition, drug optimization that gives equal weight to drug potency/specificity, drug tissue exposure/selectivity, and the dose required to balance clinical efficacy/toxicity improves drug candidate selection and clinical dose optimization.

Typically, new drugs take over a decade and cost more than $1 billion to develop. Given the high drug development failure rates, advancing a drug candidate to a phase I clinical trial requires a relentless quest for innovation. It is a considerable achievement for any pharmaceutical company or academic research facility.

This article shares those successes within oncology drug development in 2023, the trends and setbacks, and what’s on the horizon in 2024.

Novel oncology drugs approved by the FDA in 2023

In 2023, the FDA approved 13 novel anti-cancer therapies. Here’s an overview of these innovative new options.

Table: Novel oncology drugs approved in 2023

Drug Maker Type
of drug
Indication When
Augtyro repotrectinib Bristol
Non small-cell
lung cancer
The first ROS1
inhibitor to be
approved to treat
patients whose
tumors did not
respond to or
relapsed following
treatment with a
previous ROS1
Columvi glofitamab-gxbm Genentech BiTE Certain types of
diffuse large
B-cell lymphoma
(DLBCL) or large
B-cell lymphoma
For patients
who have
received two
or more lines
of therapy
Elrexfio elranatamab-bcmm Pfizer BiTE Relapsed or
multiple myeloma
For adults who
have received
at least four prior
lines of therapy
Epkinly epcoritamab-bysp Monograph BiTE Relapsed or
refractory diffuse
large B-cell
lymphoma (not
otherwise specified)
and high-grade
B-cell lymphoma
For patients who
have received
two or more
lines of therapy
Fruzaqla fruquintinib Takeda TKI Refractory,
colorectal cancer
Jaypirca pirtobrutinib Eli
Relapsed or
refractory mantle
cell lymphoma
For adults who
have had at least
two lines of
systemic therapy,
including a
BTK inhibitor
Loqtorzi toripalimab-tpzi Coherus
Recurrent or
Used with or
following other
Ogsiveo nirogacestat SpringWorks
desmoid tumors
Orserdu elacestrant Menarini
SERD Estrogen
human epidermal
growth factor
advanced or
metastatic breast
cancer with
For patients
who have had
at least one
line of
endocrine therapy
Talvey talquetamab-tgvs Johnson
& Johnson
BiTE Relapsed or
For adults who
have received at
least four prior
Truqap capivasertib AstraZeneca TKI Breast cancer
that meets
certain criteria
Vanflyta quizartinib Daiichi
TKI Newly diagnosed
acute myeloid
leukemia that
meets certain
For use as part
of a treatment
Zynyz retifanlimab-dlwr Incyte ICI Metastatic or
recurrent locally
advanced Merkel
cell carcinoma

The trends and setbacks in oncology drug approvals in 2023

In 2023, we saw significant oncological advancements in the treatment of hematologic malignancies, with the FDA approval of talquetamab-tgvs (Talvey) and elranatamab-bcmm (Elrexfio), both new bispecific T cell-engaging antibodies, in relapsed/refractory multiple myelomas.

The FDA approved four new bispecific T cell-engaging antibodies (BiTEs) and a raft of new small-molecule therapies. However, although many antibody-drug conjugates (ADCs) have been approved in recent years, they were absent from the new oncology drug approvals list in 2023.

BiTEs (Bispecific T cell engagers):

First proposed in the 1960s, this class of oncology drugs utilizes a patient’s immune system to fight cancer cells. The four FDA approvals in 2023 brought the total number of BiTEs to seven.

Small-molecule drugs:

These include targeted therapies like kinase inhibitors that are small enough to enter individual cells to deliver targeted treatments. Small-molecule drugs proved a real success story for 2023, with eight novel small-molecule drugs receiving FDA approval for oncology indications.

ADCs (Antibody-drug conjugates):

These drugs deliver chemotherapy to cancer cells without harming healthy cells in the body. First approved in 2000, over a dozen ADC types are available, Although 2023 did not witness the emergence of new ADC types as seen in previous years, the field is now characterized by evolving strategies for this class of therapeutics.

Despite this exciting progress, the year was not without its setbacks. Apart from general financial challenges in 2023 combined with the lasting effects of trial disruptions, which impeded therapeutic progress during the pandemic, the development of anti-CD47 antibodies was affected by the closure of developers and the shelving of development programs following concerns over safety and efficacy. Once considered a promising drug candidate to boost chemotherapy in the treatment of blood cancers,new strategies are emerging its future now looks uncertain.

In February, Gilead announced it had discontinued its study of magrolimab in acute Myeloid Leukemia. And in the same month, Arch Oncology also ended work on an anti-CD47 antibody before closing its offices. Similarly, AbbVie pulled out of co-development of anti-CD47 drug candidate lemzoparlimab with I-Mab and ALX Oncology ended its programs in MDS and AML after poor results.

What can we expect from oncological drug development in 2024?

The FDA issued 14 oncology approvals in the first quarter of 2024, including the first tumor-infiltrating lymphocyte (TIL) cell therapy to reach the market.

  • Lifileucel (Amtagvi) is a new immunotherapy indicated for treating adult patients with unresectable or metastatic melanoma. It is the first cancer treatment that uses immune cells called tumor-infiltrating lymphocytes (TILs).

  • Like CAR T-cell therapy, lifileucel is made using a patient’s T cells. However, unlike CAR T-cell therapy, in which T cells are collected from the patient’s circulating blood, TIL therapy uses T cells collected from the patient’s tumor.

April was another excellent month for oncology therapies receiving FDA approval for diseases including HER2-positive solid tumors, early-stage non-small cell lung cancer (NSCLC), multiple myeloma, and other cancer types. May saw the earlier-than-expected approval of tarlatamab for treating advanced small-cell lung cancer (SCLC). Tarlatamab is an investigational, first-in-class, bispecific T cell engager designed to target DLL3 on SCLC cells and CD3 on T cells.

Looking ahead, oncology drug development trends from the last couple of years are set to continue, with more therapies coming from emerging companies—up to 71% in 2022 from 51% in 2017 . And, increased numbers of drugs being developed in non-US countries, with China and Japan leading the charge for worldwide innovation.

The pharmaceutical and biopharmaceutical industries recognize the overwhelming need to accelerate the drug discovery process and increase drug development success rates. With this in mind, they are embracing recent advances in artificial intelligence (AI), cutting-edge chemical technology, and small-molecule chemical probes and tools, determined to improve failure rates and ultimately increase the number and range of therapies available to patients. It will be interesting to see how these technological and scientific advancements impact the success rates for drug discovery and development in the years to come.

Contact us today to explore how our platforms and services can accelerate your drug research and development process.