Memorial Sloan Kettering and the Chinese Thoracic Oncology Group Urge International Harmonization to Accelerate Cancer Drug Approvals at Annual Event

Memorial Sloan Kettering Cancer Center, December 28, 2022

The fifth annual MSK-CTONG Symposium highlighted the importance of global regulatory harmonization in clinical trials to expedite access to cancer treatments for patients worldwide. The symposium, hosted online for a global audience in December 2022, showcased collaborations between the Chinese Thoracic Oncology Group (CTONG) and Memorial Sloan Kettering Cancer Center (MSK) to advance scientific, educational, and regulatory aspects of clinical trials for new cancer therapies. This initiative aims to benefit millions of patients by accelerating testing and approvals of cancer treatments through international partnerships.

The MSK-CTONG collaboration, focusing on precision cancer therapies for lung cancer, aims to enhance patient access to international clinical trials and facilitate educational exchanges between healthcare professionals in the U.S. and China. The symposium highlighted the significant role of international regulatory harmonization in potentially saving 1-2 million lives annually, as demonstrated by a recent MSK-led study in collaboration with Asia Society and the Bloomberg New Economy International Cancer Coalition. The collaboration between MSK and CTONG seeks to promote greater access to new cancer drugs and foster global regulatory dialogue across borders.

Furthermore, the Symposium addressed the strategic importance of initiatives like Project Orbis, led by the FDA Oncology Center of Excellence, in accelerating timelines for new drug applications through simultaneous regulatory reviews by various countries. The event emphasized the need for enhanced international collaboration to streamline regulatory processes, improve quality of care, and facilitate faster access to innovative cancer medicines. By promoting regulatory harmonization, partnerships like MSK-CTONG and Project Orbis aim to drive advancements in cancer treatment on a global scale, benefiting diverse patient populations across different regions.

To read the full article, please visit the Memorial Sloan Kettering Cancer Center website.

Targeting KRAS in cancer

Anupriya Singhal,  Bob T. Li &  Eileen M. O’Reilly 

Nature Magazine, April 18, 2024

This piece in Nature Medicine that outlines the strategic thinking and future directions in the KRAS battle. Combination therapies against KRAS are underway, and first-in-human clinical trials of new allele specific molecules are already here, including promising inhibitors of KRAS G12D.

Apart from furthering our advances against lung cancers, we have a comprehensive plan to beat some of the most recalcitrant malignancies.

The full article is behind a paywall at Nature Magazine.

Dr Li on the Investigation of BDC-1001 in HER2-expressing Solid Tumors

Oncology Live – June 13, 2023

C4C Taskforce Member Dr Bob T. Li discusses the results of a phase 1/2 study of the first-in-class immune-stimulating antibody conjugate BDC-1001 in patients with advanced HER2-expressing solid tumors.

Watch the interview on Oncology Live

Breakthrough Lung Cancer Treatment FOUND in Precision Medicine | Dr. Bob Li

Centerpoint, February 21, 2023

On Centerpoint, Dr. Bob Li joins Doug McKelway to discuss new breakthroughs in the area of precision medicine and its effectiveness against lung cancer.

Watch the full Interview on YouTube

Study on International Regulatory Harmonization Published in Harvard Business Review

Call for a Human Moonshot at Forbes China Healthcare Summit

Greg Simon, the Founding Executive Director of the White House Cancer Moonshot called for a “Human Moonshot” to promote international cancer clinical trials cooperation and bring breakthroughs to people all over the world

FDA grants double accelerated approval of trastuzmab deruxtecan (Enhertu)

FDA granted accelerated approval of trastuzumab deruxtecan (Enhertu) for patients with HER2-low breast cancer and HER2-mutant lung cancer based on international trials.

A Post-Pandemic Era White Paper Published in Nature Magazine

European Union Clinical Trials Regulation Came into Effect

Biden reignites the Cancer Moonshot, setting ambitious goals: to reduce the death rate from cancer by at least 50 percent over the next 25 years

International Cancer Coalition Launch

In 2021, the International Cancer Coalition officially launched at the Bloomberg New Economy Forum in Singapore.