Experts concluded the Academy of Managed Care Pharmacy (AMCP) Nexus 2025 meeting in National harbor, Maryland, by emphasizing how new indications within existing drug classes, along with the introduction of novel agents, are driving more targeted, accessible, adn value-driven cancer care.
AMCP Nexus 2025: Oncology Pipeline Highlights Innovation, Access, and Value
Table of Contents
Evolving Oncology Spending Trends, Drug Advancement Landscape
Boss opened the session with an overview of recent trends in oncology pharmaceutical spending and drug development.She noted that global oncology spending reached $252 billion in 2024 and is projected too climb to $441 billion by 2029.
“This increase in spending is driven by the increase in access but also by the use of branded and novel medications,” Boss said.
She added that the cost of novel therapies remains high, with the median price of new oncology agents launched in 2024 being $411,855.
“Uptake of biosimilars and generic medication should provide some opportunities for savings within the class, but it’s unlikely to really offset those rising costs,” boss said.
As of September 15,2025,there have been 30 oncology FDA approvals this year,including 7 accelerated approvals and 1 biosimilar,down from 45 approvals in 2024. Despite this decrease, she noted that the oncology pipeline shows no signs of slowing down, with about 1600 treatments and vaccines currently in development.
Boss also highlighted that the initiation of new oncology trials increased last year and is up 12% from 2019, with 74% evaluating medicines for rare cancers and 79% focused on solid tumors. Antibody-drug conjugates (ADCs) are the fastest-growing modality in solid tumors, she added, with a 32% annual increase in the number of related clinical trials initiated.
Boss and Bhatt then reviewed FDA approvals in the oncology space as the AMCP Nexus meeting in Las Vegas last October, underscoring the expansion of existing drug classes and the introduction of novel agents.
Recent FDA Approvals Expand adcs, Bispecific Antibodies Across Cancer Types
Recent FDA
## Recent Advances in NSCLC Treatment
Recent years have witnessed significant strides in the treatment landscape of non-small cell lung cancer (NSCLC). Antibody-drug conjugates (ADCs) are emerging as a powerful therapeutic modality, with futibatinib (lytgobi; Taiho Oncology) gaining approval for patients with locally advanced or metastatic NSCLC with previously treated *FGFR2* alterations.3 This approval extends to individuals who have previously received EGFR-directed therapy and platinum-based chemotherapy.
Another ADC approved in the NSCLC space is telisotuzumab vedotin-tllv (Emrelis; AbbVie), also known as Teliso-V. On May 14, 2025, it was approved for adult patients with locally advanced or metastatic nonsquamous NSCLC with high c-Met protein overexpression who have received a prior systemic treatment.4
bispecific antibodies have also expanded their indications. for example, linvoseltamab-gcpt (Lynozyfic; Regeneron), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, received FDA approval.
recent FDA Approvals and Emerging Oncology Therapies
The oncology landscape is rapidly evolving, with a surge of new FDA approvals impacting treatment paradigms. Experts have highlighted a trend toward incremental advancements alongside the introduction of truly novel, first-in-class therapies.
Incremental Advances in Existing Targets
Many recent approvals represent refinements within established treatment strategies. these include new formulations, combinations, or expanded indications for existing drugs. For example, the FDA approved
Emerging First-in-Class Oncology Therapies
In contrast, the experts noted that several recent FDA approvals introduced first-in-class therapies to the oncology landscape.1 Among these are menin inhibitors, which block the interaction between menin and other proteins to prevent activation of genes that drive cell growth, ultimately inhibiting cancer cell proliferation.
Bhatt highlighted that the first menin inhibitor, revumenib (Revuforj; Syndax Pharmaceuticals), received FDA
Tabelecleucel (Ebvallo; Atara Biotherapeutics), currently under review with a PDUFA date of January 10, 2026, could become the first allogeneic, non-genetically modified T-cell therapy for Epstein-Barr virus-positive posttransplant lymphoproliferative disease. Its “off-the-shelf” nature could enable rapid treatment for highly immunosuppressed patients.
Recent FDA Approvals in Non-Small Cell Lung Cancer (NSCLC)
The treatment landscape for non-small cell lung cancer (NSCLC) is continually evolving, with recent FDA approvals offering new hope for patients. These approvals target specific genetic mutations and protein expressions, representing a move towards more personalized cancer care.
Datopotamab Deruxtecan for EGFR-Mutated NSCLC:
In June 2025, the FDA approved datopotamab deruxtecan for patients with EGFR-mutated NSCLC. This approval marks a significant advancement, providing a new treatment option for a common subtype of lung cancer.(Steinzor P. AJMC. June 23, 2025. Accessed November 5, 2025. https://www.ajmc.com/view/fda-approves-datopotamab-deruxtecan-for-egfr-mutated-nsclc)
Teliso-V for Advanced NSCLC with High c-Met Overexpression:
May 2025 brought the FDA approval of Teliso-V, indicated for the treatment of advanced NSCLC characterized by high c-Met protein overexpression. This approval addresses a specific biomarker, offering a targeted therapy for patients whose tumors exhibit this characteristic. (Klein HE. AJMC. May 14, 2025. Accessed November 5, 2025. https://www.ajmc.com/view/teliso-v-approved-to-treat-advanced-nsclc-with-high-c-met-protein-overexpression)
These recent approvals underscore the ongoing progress in NSCLC treatment and the importance of biomarker testing to identify patients who may benefit from these targeted therapies.
Recent FDA Approvals in Oncology: A November/December 2024 Update
The FDA has recently approved several novel therapies for various cancers, marking significant advancements in oncology. Here’s a summary of key approvals from november and December 2024:
Zanidatamab-hrii for HER2+ Biliary Tract Cancer:
In November 2024,the FDA approved zanidatamab-hrii for the treatment of HER2-positive biliary tract cancer. This approval offers a new therapeutic option for patients with this challenging cancer type. (Santoro C.AJMC. November 21, 2024.Accessed November 5, 2025. https://www.ajmc.com/view/fda-approves-zanidatamab-hrii-for-her2-biliary-tract-cancer)
Zenocutuzumab-zbco for non-Small cell Lung Cancer and Pancreatic Adenocarcinoma:
December 2024 brought accelerated approval for zenocutuzumab-zbco, indicated for both non-small cell lung cancer and pancreatic adenocarcinoma. This approval expands treatment possibilities for patients battling these aggressive malignancies. (FDA. News release.December 4, 2024. Accessed November 5, 2025. https://www.fda.gov/drugs/resources-information-approved)
Revumenib Approved for Aggressive Leukemia
The FDA has approved revumenib (Rezlidhia) for adults with relapsed or refractory (R/R) acute myeloid leukemia (AML) whose leukemia has a KMT2A translocation. This approval marks a significant step forward in treating a particularly challenging subtype of AML.
Understanding KMT2A-Rearranged AML
KMT2A, formerly known as MLL, is a gene involved in normal blood cell development. When it becomes rearranged (translocated) in AML, it often leads to a very aggressive form of the disease. Patients with KMT2A-rearranged AML typically have poor outcomes with standard chemotherapy. Revumenib specifically targets the abnormal protein created by this translocation.
How Revumenib Works
Revumenib is a menin MLL1 inhibitor. It works by binding to the menin protein, which is crucial for the survival of leukemia cells with the KMT2A rearrangement.By blocking menin, revumenib disrupts the leukemia cells’ ability to grow and proliferate. It’s administered orally, offering a convenient treatment option for patients.
Clinical Trial Results
the approval is based on data from the pivotal Phase 2 AUGMENT trial. The trial demonstrated a complete remission rate of 36% among patients treated with revumenib. Additionally, the median duration of remission was 12.9 months, a clinically meaningful advancement for this patient population. common side effects observed in the trial included differentiation syndrome, infections, and decreased appetite.
Crucial Considerations
Revumenib is not a cure, but it provides a new option for patients who have fatigued other treatments. It’s crucial for patients to be tested for the KMT2A translocation before starting treatment to ensure they are eligible for revumenib. Close monitoring for differentiation syndrome, a potentially life-threatening complication, is also essential.
Access and Future Directions
Revumenib is now available for eligible patients. Researchers are continuing to investigate revumenib in combination with other therapies to further improve outcomes for individuals with KMT2A-rearranged AML.The approval of revumenib represents a significant advance in precision medicine for leukemia.
Publication Date: 2025/11/05 20:48:51
Sources
- FDA Approves Revumenib for R/R Acute Leukemia with a KMT2A Translocation. https://www.ajmc.com/view/fda-approves-revumenib-for-r-r-acute-leukemia-with-a-kmt2a-translocation
- Joszt L. Revumenib granted FDA approval for R/R NPM1-mutated AML. AJMC. October 24, 2025. Accessed November 5, 2025.