PYC Therapeutics Ltd.’s lead candidate, VP-001, is entering the clinic, and the RNA therapy could be the first potential treatment for retinitis pigmentosa type 11, which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age.
In the string of successes and frustrations generated by their five-year collaboration, Merck & Co. Inc. and Eisai Inc. can now add a few more frustrations. The companies are discontinuing the phase III LEAP-003 study of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for first-line treatment of unresectable or metastatic melanoma because it did not improve overall survival (OS) vs. Keytruda as a monotherapy. Also, the phase III LEAP-017 trial evaluating the combination in unresectable and metastatic colorectal cancer did not meet its primary endpoint of OS.
The radiopharma field has garnered increasing attention in recent years due to big-ticket deals like Bayer AG's $2.9 billion acquisition of Algeta ASA and Novartis AG's nearly $6 billion spent on buying Advanced Accelerator Applications SA and Endocyte Inc. As a result, competition is ratcheting up and pipelines are exploding with new combinations of different drugs. The global radiopharmaceuticals market was estimated to be valued at $6.7 billion in 2020, a number expected to reach $11.5 billion by 2027, according to a 2022 William Blair report.
The possibilities of cures for cancer and other tough-to-treat diseases and the ability to further personalize medicine are creating a lot of excitement about the future of radiopharmaceuticals as both therapy and diagnostics. To reach that future, industry and researchers will have to overcome a lot of challenges, not the least of which stem from the multiple government agencies involved in regulating the source material, development, distribution and use of radioactive drugs and devices.
Radiopharmaceuticals require sophisticated infrastructure, with just-in-time radioactives delivered to patients who must isolate while receiving the therapy. Quality control and numerous layers of regulation makes for a daunting space to enter.
Supply issues are a “major concern for the whole industry and for the medical community as well, because they see targeted radiotherapy as a very promising field with very interesting results in the clinic, but they are concerned that drugs may not be available for a large number of patients, and it is a legitimate concern,” Orano Med SAS CEO Julien Dodet said.
It all goes to show how a good idea can’t be kept down. Madam Curie started radiopharmaceuticals in the late 1800s and now it’s a multibillion-dollar industry. BioWorld’s eight-part series on a new era of radiopharmaceuticals reveals their increasing importance as part of cancer treatments because they have fewer side effects and cause far less damage to tissue than previously. The big idea is taking the hallmarks of two cancer therapies – radiology and chemotherapy – and merging them. That’s what makes this evolving technology a disrupter.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Aim Immunotech, Astellas, Brim, Edesa, Everest Medicines, Gennova, Hutchmed, Inflarx, Seagen, Shionogi.
Global interest in radiopharmaceuticals is growing, and some big deals in the space have sparked interest in the last few years. Novartis AG has spent about $6 billion in acquisitions and is seen as the global leader.
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