Cancer Drugs Fast-Tracked by the FDA in May 2025

By Editorial Team
In May 2025, the U.S. Food and Drug Administration (FDA) granted fast track designations to several key oncology drugs for cervical, blood, and lung cancers, among others.

Cancer Drugs Fast-Tracked by the FDA in May 2025

ISB 2001 for Relapsed/Refractory Multiple Myeloma

On May 5, Ichnos Glenmark Innovation announced that the FDA granted fast track designation to ISB 2001, an investigational trispecific antibody, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“Our trispecific candidate is designed to enhance tumor targeting while reducing on-target, off-tumor toxicity,” said Cyril Konto, MD, CEO and president of IGI, in a news release.

ISB 2001 was well-tolerated with manageable toxicities and demonstrated robust antimyeloma activity in heavily pretreated patients, according to data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7514).

ADRX-0706 for Advanced Cervical Cancer

On May 6, Adcentrx Therapeutics announced that the FDA granted fast track designation to its lead program, ADRX-0706, a Nectin-4 ADC, for the treatment of patients with advanced or metastatic squamous cell cervical cancer.

The designation “underscores the significant unmet need in advanced cervical cancer and marks another meaningful milestone for Adcentrx,” said Hui Li, PhD, founder and CEO of Adcentrx, in a news release. “This recognition, together with the early clinical signals observed for ADRX-0706, reinforces the best-in-class potential of our Nectin-4 ADC and provides the opportunity for enhanced regulatory dialogue as we continue advancing this important program through clinical development.”

ADRX-0706 demonstrated a favorable safety profile, manageable toxicities, and encouraging antitumor activity in multiple heavily pretreated tumors with moderate to high Nectin-4 expression, according to data presented at ASCO 2025 (Abstract 3018).

Givinostat for Polycythemia Vera

Also on May 6, Italfarmaco S.p.A. announced that the FDA granted fast track designation to givinostat, an orally administered histone deacetylase inhibitor, for the treatment of patients with polycythemia vera (PV).

The designation “underscores the urgent need for innovative treatments for PV and highlights the potential of givinostat to make a meaningful difference,” said Paolo Bettica, MD, PhD, chief medical officer at Italfarmaco Group, in a news release. “We look forward to working closely with the FDA as we plan for completion of our phase 3 clinical trial.”

ZL-1310 for Extensive-Stage Small Cell Lung Cancer

On May 19, Zai Lab announced that the FDA granted fast track designation to its potential first-in-class DLL3 antibody-drug conjugate (ADC) for the treatment of patients with extensive-stage small cell lung cancer (SCLC).

The designation “highlights the significant need for expanded treatment options for patients with SCLC and represents an important step in our efforts to advance a novel therapeutic option as quickly as possible,” said Rafael G. Amado, MD, president, head of global research and development at Zai Lab, in a news release.

ZL-1310 previously received an orphan drug designation for SCLC and most recently demonstrated a tolerable safety profile and promising antitumor activity in relapsed or refractory extensive-stage SCLC, according to data presented at ASCO 2025 (Abstract 3041).

CPO301 for Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer

Also on May 19, CSPC Pharmaceutical Group Limited announced that the FDA granted fast track designation to CPO301, a first-in-class EGFR-targeting ADC, for the treatment of adult patients with advanced or metastatic nonsquamous non-small cell lung cancer without EGFR mutations or other actional genomic alterations who have progressed on platinum-based chemotherapy and an anti-PD-L1 antibody. CPO301 has previously received two fast track designations from the FDA, in June 2023 and September 2024.

EBC-129 for Pancreatic Ductal Adenocarcinoma

On May 28, the Experimental Drug Development Centre (EDDC) announced that the FDA granted fast track designation to EBC-129, a first-in-class ADC, for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC).

“The FDA’s fast track designation for EBC-129 underscores the promise of this novel ADC in addressing the critical need for expanded treatment options for PDAC patients and represents an important step in our efforts to accelerate its development. We view this as both a validation of our efforts and a responsibility to move decisively to advance EBC-129 as a new option to patients in need,” said Professor Damian O’Connell, CEO of EDDC, in a news release.

The drug has demonstrated promising clinical activity and a manageable safety profile in heavily pretreated patients, according to data presented at ASCO 2025 (Abstract 4018). Further evaluation of EBC-129, both as a monotherapy and in combination with chemotherapy, is planned.

© 2025 HealthCentral LLC. All rights reserved.
Source: https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-may-2025

Comments

Post a Comment

Popular posts from this blog

Fenbendazole vs Ivermectin for Cancer: Differences and Which Is Better?

By Editorial Team
Image
Cancer patients are increasingly inquiring about the use of the anthelmintic drugs Fenbendazole (FenBen) and Ivermectin (IVM) as potential treatments for cancer. Notably, these patients typically fall into two distinct groups, neither of which represents the usual stage 1 or 2 cancer cases where conventional therapies often show promise. The first group consists of older men whose lung or prostate cancer has recurred. Having undergone conventional treatments previously without success, they express skepticism about its effectiveness this time around. The second, larger group comprises younger patients under 40 dealing with aggressive breast cancer, colorectal cancer, or lymphoma—forms of early-onset cancers that appear to lack the typical mutations observed in traditional cases. This article aims to delve into the differences between Fenbendazole and Ivermectin by examining their me...
Read more

Exploring Ivermectin, Mebendazole and Fenbendazole as Aggressive Cancer Treatments: Research, Protocols, and Controversies (2025)

By Editorial Team
Image
Fenbendazole and ivermectin, both antiparasitic drugs that have shown potential in cancer treatment through several mechanisms, such as slowing cancer cell growth and boosting the immune response. Fenbendazole is being studied for its ability to disrupt energy production in cancer cells, effectively hindering their growth. Ivermectin, on the other hand, has been explored in combination with checkpoint inhibitors to boost the immune system's response to tumors—especially in challenging cases like triple-negative breast cancer. Introduction Cancer remains a leading cause of morbidity and mortality worldwide, with an increasing incidence of aggressive and treatment-resistant tumors such as triple-negative breast cancer (TNBC), pancreatic adenocarcinoma, and glioblastoma. Despite significant advances in targeted therapies and immunotherapies, many patients continue to face limited effective options, highlighting an urgent need for novel, affordable, and accessible treatment strategies....
Read more

Top 10 Cancer Fighting Supplements: Evidence Based Literature Review (2025)

By Editorial Team
Image
Are you overwhelmed by conflicting advice on cancer, diet, and supplements ? You’re not alone. With so many claims out there, it’s hard to separate fact from fiction . Can certain foods lower your cancer risk ? Are some foods increasing it without you realizing? What about vitamin and mineral supplements —do they help prevent cancer, or could they actually increase your risk ? The term " anti-cancer supplements " can be misleading. While some nutrients support the body in cancer prevention or treatment, others may interfere with therapies or even pose risks. This guide compiles over 300 scientific references on cancer, diet, and supplements—helping you navigate the facts with ...
Read more

Fenbendazole and Ivermectin for Cancer Case Series: Over 150 Case Reports (2025)

By Editorial Team
Image
Anecdotal reports and preliminary studies suggest that ivermectin and fenbendazole, both antiparasitic drugs, may have potential anticancer effects when used alongside other treatments.  Many people immediately dismiss the potential of ivermectin and fenbendazole when they learn it is “horse or dog medicine”. That initial reaction is overcome when genuine human success stories are told including the lack of serious side effects. The testimonials you are about to read are from individuals who have bravely shared their experiences in the hope of inspiring and uplifting others. These are raw human accounts, unfiltered by gatekeepers—not peer-reviewed studies—but they offer insights that may be valuable to those searching for options. However, we acknowledge that robust clinical trials are needed to provide more conclusive scientific evidence. Table of Contents: Editor's Preface Introduction Fenbendazole and Ivermectin Case Series Compilation (alphabetical) Breast Cancer Success Storie...
Read more

Fenbendazole Dosage for Cancer in Humans: Benefits, Risks, and Guidelines (2025)

By Editorial Team
Image
What is Fenbendazole? Fenbendazole is an anthelmintic drug commonly used to treat parasitic infections in animals. However, recent research and anecdotal reports suggest it may have potential anticancer properties in humans. How Does Fenbendazole Work for Cancer? Fenbendazole is believed to work by disrupting microtubules in cancer cells, leading to cell cycle arrest and apoptosis (cell death). Some studies suggest it may also modulate glucose metabolism, limiting cancer cell energy supply. Recommended Fenbendazole Dosage for Cancer in Humans The commonly referenced Joe Tippens Protocol suggests the following dosage: Potential Side Effects of Fenbendazole in Humans While generally considered safe, potential side effects may include: Gastrointestinal discomfort (nausea, diarrhea, bloating) Liver enzyme elevation (rare) Bone marrow suppression (rare) Safety and Precautions Medical Supervision: Always consult with a doctor, especially if combining with other treatments. Drug Interaction...
Read more

Ivermectin for Cancer Treatment: Protocols and Evidence (2025 Edition)

By Editorial Team
Image
Ivermectin, a drug primarily used to treat parasitic infections, has gained attention for its potential anti-cancer properties, particularly in alternative treatment protocols. Popularized by figures like Dr. William Makis, these protocols combine ivermectin with supplements and lifestyle changes to target aggressive cancers. This article explores the science, protocols, case reports, risks, and controversies surrounding ivermectin’s use in cancer treatment, providing a balanced guide for readers. What is the Ivermectin Cancer Protocol? Ivermectin cancer protocols, notably those developed by Dr. William Makis, combine ivermectin with supplements like curcumin, vitamin D, and berberine, alongside dietary and lifestyle changes. These protocols are tailored to cancer severity, with higher doses recommended for aggressive cases. The term “turbo cancers,” used by some proponents, refers to rapidly progressing cancers, though it is not a standard medical term and lacks clear scientific defin...
Read more

Fact Check: Can Ivermectin and Fenbendazole Help Treat Cancer?

By Editorial Team
Image
Ivermectin and fenbendazole, originally developed as antiparasitic drugs, are sparking hope in the fight against cancer, fueled by inspiring stories like those shared by actor  Mel Gibson on The Joe Rogan Experience , where he celebrated friends’ remarkable recoveries. While these medications aren’t yet standard cancer treatments, early research is uncovering exciting potential. Scientists are encouraged by promising lab studies and are calling for more clinical trials to confirm their effectiveness and ensure safe use in humans, paving the way for innovative, accessible therapies that could transform lives. Introduction and Context According to a January 22, 2025 fact-check article by AFP: "The anti-parasitic drugs ivermectin and fenbendazole are not currently recommended for cancer, but posts spread across social media touting the medications after actor  Mel Gibson claimed on the Joe Rogan Experience  that they cured his friends' cases of the disease. Oncology ex...
Read more

Fenbendazole and the Joe Tippens Protocol: A Comprehensive Guide (2025)

By Editorial Team
Image
The Joe Tippens Cancer Protocol has gained attention as an alternative approach to cancer treatment, popularized by Joe Tippens, a cancer survivor who credits his recovery to fenbendazole, a veterinary anthelmintic, combined with supplements. This article provides a step-by-step guide to the protocol, explores its scientific basis, shares case reports, and discusses risks and controversies to help readers make informed decisions. What is the Joe Tippens Protocol? The Joe Tippens Protocol involves fenbendazole, a drug typically used to treat parasitic infections in animals, alongside supplements and lifestyle changes. The protocol aims to disrupt cancer cell growth, though it remains experimental and lacks approval for human use by regulatory bodies like the FDA. Below is a summary of the protocol’s components, as updated in 2020: Lifestyle Recommendations : Diet : Eliminate refined sugars and processed foods; focus on whole foods like vegetables, lean proteins, and healthy fats. Exerci...
Read more

Evidence-Based Strategies for Cancer Prevention: I-Prevent Cancer Protocol (2025 Edition)

By Editorial Team
Image
Abstract Cancer remains a leading cause of mortality worldwide, with incidence rates projected to rise significantly in the coming decades. While advances in treatment have modestly improved survival, prevention through modifiable risk factors remains underemphasized. This review synthesizes current evidence on the role of diet, lifestyle, and dietary supplements in cancer prevention, drawing on systematic reviews, meta-analyses, and major guideline recommendations. The I-PREVENT CANCER protocol is introduced as a practical, evidence-based framework for reducing cancer risk. Introduction Despite trillions spent on cancer research , cancer still kills around 10 million people a year and is a leading cause of death globally. The incidence of common cancers such as breast, lung, and colon cancer is expected to increase by over 75% between 2022 and 2050.  While treatment advances offer incremental improvements in survival, prevention strategies—particularly those related to diet and l...
Read more

Eat These Foods to Starve Cancer Cells to Death (2025)

By Editorial Team
Image
Some people may not realize this, but many people have cancer cells in their bodies without presenting much danger. Fortunately, there are some common foods that can cut off cancer cell’s nutrient supply and starve them to death. Autopsies of individuals who died of trauma often reveal microscopic colonies of cancer cells , also known as in situ tumors. Some people call them “disease-free cancers.” For instance,  researchers  in Denmark performed autopsies on women aged 40 to 50, who  never  had cancer during their lifetime, and found that 39 percent of them had small cancerous lesions in their breasts. Only 1 percent of women in this age group would be diagnosed with breast cancer. Examination  of some men in their 60s showed that 46 percent of them had histological evidence of prostate cancer, which is consistent with the findings of the autopsy study. However, the prevalence of prostate cancer in men aged 60 to 70 is actually around 1 percent....
Read more

Archive

Show more