In first, cancer drugs simultaneously approved in US, Canada, Australia

BioPharma Dive | September 18, 2019

Drug approvals often occur in succession, with pharmaceutical companies typically focusing first on top markets like the U.S. and Europe. Each country has different review procedures as well, at times resulting in delays for a drug cleared in, say, the U.S. to arrive elsewhere. Project Orbis, piloted by the FDA's Oncology Center of Excellence, is designed to help coordinate cancer drug reviews, allowing for simultaneous approval and, in theory, earlier patient access to new treatments. Merck and Eisai's combination of Keytruda (pembrolizumab) and Lenvima (lenvatininb) is the first recipient of a Project Orbis review. In this case, the FDA worked alongside its counterparts in Canada and Australia but future reviews could involve other international agencies like the European Medicines Agency. "As Project Orbis expands, we look forward to welcoming additional international partners to collaborate with us in this important initiative," said acting FDA Commissioner Ned Sharpless in a statement.  Approval of Keytruda and Lenvima in endometrial cancer is an expansion of each drug's label, rather than an initial OK for either drug. In a question-and-answer document posted online, the FDA said future collaborations could involve a New Drug Application or a Biologics License Application but cautioned that those reviews "may be more complex due to proprietary information involved."

Spotlight

ABI Research is a global technology intelligence firm delivering actionable research and strategic guidance to technology leaders, innovators, and decision-makers around the world.

Spotlight

ABI Research is a global technology intelligence firm delivering actionable research and strategic guidance to technology leaders, innovators, and decision-makers around the world.

Related News

BUSINESS INSIGHTS, PHARMA TECH

Tonix Pharmaceuticals to Obtain an Exclusive License from Columbia University

Tonix Pharmaceuticals | February 14, 2023

On February 13, 2023, Tonix Pharmaceuticals, a leading clinical-stage biopharmaceutical firm, announced that it has exercised an option to acquire an exclusive license from Columbia University to develop a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the prophylaxis or treatment of SARS-CoV-2 infection. COVID-19 is caused by SARS-CoV-2. Tonix Pharmaceuticals and Columbia University announced a research collaboration and option agreement in 2020, which resulted in the development of the licensed mAbs. Although the FDA granted emergency use authorization (EUA) to five mAb products containing seven distinct mAbs for either prophylaxis or treatment of COVID-19, none stayed available or functional since January 26, 2023, when the FDA stated that the last remaining mAb, Evusheld®, is no longer authorized. Previously, either FDA or the National Institutes of Health COVID Treatment Guidelines Panel had revoked recommendations or clearances for the other mAbs. Until recently, the earlier EUA-approved products were obtained from the blood of humanized mice or COVID-convalescent patients. Columbia University's TNX-3600 fully human mAbs were generated utilizing a proprietary system that involved a human hybridoma fusion partner. The firm feels that murine monoclonal antibodies, such as TNX-4100, have the capacity to generate antibodies with a high affinity that detect distinct epitopes on the SARS-CoV-2 spike protein. This is due to the fact that mice have a different antibodies repertoire than humans, and the technology for making antibodies optimizes the selection of relevant B cells via harvesting approach, immunization timing and screening platform. About Tonix Pharmaceuticals Founded in 2007, Tonix Pharmaceuticals is a clinical-stage biopharmaceutical firm committed to finding, acquiring, licensing, and developing therapies for the treatment and prevention of diseases and the alleviation of human suffering. Its pipeline is focused on rare diseases, immunology, infectious diseases, and central nervous system (CNS) product candidates. The company's immunology portfolio consists of biologics for the treatment of organ transplant rejection, cancer and autoimmunity. At the same time, its infectious disease portfolio includes next-generation COVID-19 vaccines and vaccinations against smallpox and monkeypox.

Read More

BUSINESS INSIGHTS, PHARMA TECH

Epredia and Aiforia Join ReMDO’s RegeneratOR Innovation Accelerator

Epredia | January 19, 2023

On January 18, 2023, PHC Group, a healthcare company renowned in diagnostics and life sciences, announced that it would join the RegeneratOR Innovation Accelerator to grow its presence in regenerative medicine. The Wake Forest Institute for Regenerative Medicine (WFIRM) and the RegenMed Development Organization (ReMDO) are the two institutions expediting the discovery and translation of regenerative medicine therapeutics located in the Innovation Quarter. PHC Group, being an early partner of ReMDO's RegeneratOR Test Bed, offered advanced tissue processing technologies as well as support to researchers for prototype and product development. In addition, another ReMDO program, the Innovation Accelerator, was formed to give space and support to companies with innovative or emerging regenerative medicine technologies. PHC Group is now opening a local office within the Innovation Accelerator. Its holding companies and partners include Epredia, a precision cancer diagnostics company whose products are used by researchers and pathologists worldwide, and Aiforia, a medical software company that develops artificial intelligence software for image analysis in pathology. Aiforia's collection of preclinical and clinical pathology instruments is distributed globally by Epredia. The firms work together to deliver slide imaging and AI-based solutions that enable researchers to investigate and extract information beyond the scope of human visual perception. Thus, clinical research, drug discovery, and translational studies with the goal of better understanding disease states are all linked together through diagnostic microscopic imaging and artificial intelligence. PHC Group's presence, along with Epredia and Aiforia's superior technology assistance at the Innovation Accelerator, will also pave the path for RegeneratOR's newest initiative, the RegenMed Clinical Trials Catalyst. As a part of Wake Forest University School of Medicine and the academic core of the newly merged Advocate Aurora Health and Atrium Health, the Catalyst will have access to 5.5 million patients, serving 67 hospitals in North Carolina, Wisconsin, South Carolina, Georgia, Alabama, and Illinois. About Epredia Epredia is a leading comprehensive laboratory solutions provider for instruments and consumables in anatomic pathology, histology, and cytology. It was established through an acquisition by PHC Group from Thermo Fisher Scientific. The company provides solutions for cancer diagnostics through its renowned brands: Richard Allen Scientific, Erie Scientific, Microm, Shandon, and Menzel-Glaser. Epredia is committed to realizing its aim of advancing cancer diagnostics for patients worldwide in order to save lives.

Read More

PHARMACY MARKET, PHARMA TECH

Jazz Pharmaceuticals Maintains Exclusive Rights to Develop and Sell Zymeworks' Zanidatamab

Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022

Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022. A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found. Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers. Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug. Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022. About Jazz Pharmaceuticals Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible. About Zymeworks Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.

Read More