Pfizer’s Braftovi received accelerated FDA approval in December as a first-line treatment for metastatic colorectal cancer with a particular genetic mutation. The pharma giant now says the drug has hit primary and secondary goals of its Phase 3 clinical trial.
Geneoscopy received approval for its noninvasive colorectal cancer screening test, which the FDA designated as a breakthrough device. This marks only the second time the FDA has issued an approval for a molecular diagnostic test for colorectal cancer — and the first time the agency has done so for a colorectal cancer test that uses RNA.
A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices.
FogPharma’s lead program is a peptide that blocks a difficult-to-drug pathway inside of cells. The new financing will go toward an ongoing Phase 1/2 study in advanced solid tumors and support development of pipeline programs for other elusive cancer targets.
G1 Therapeutics said its drug met the main goal of a Phase 3 study in colorectal cancer, but the preliminary results also show measures of survival are better in the placebo arm. The company is stopping the colorectal cancer study.
The Hutchmed drug, fruquintinib, is already approved in China for colorectal cancer. Takeda Pharmaceutical gets global rights to the small molecule, which has started a rolling submission with the FDA and is being readied for regulatory submissions in Europe and Japan.
The breast cancer solution will help determine which patients would benefit from targeted therapies and which patients could avoid chemotherapy. Meanwhile, the colorectal solution will be able to match patients with the most effective treatment sooner.
Transitioning to PDPM models significantly shifted the healthcare industry. By replacing the RUG system, healthcare providers cut waste and more accurately reflect the care each patient received.
Since it measures the total amount of circulating DNA (ctDNA) in a patient’s bloodstream using a simple blood draw, ctDNA liquid biopsy tests offers oncologists with an accurate, molecular, real-time cancer detection tool. It also helps to determine cancer staging and can help assess how aggressive the treatment regimen should be.
Celyad Ocology has voluntarily paused a clinical study evaluating its off-the-shelf CAR T-cell therapy in colorectal cancer following the report of two patient deaths. The investigation is ongoing, but the company said that both patients exhibited “similar pulmonary findings.”
Stand Up To Cancer and Exact Sciences are teaming up to increase colorectal cancer screening awareness and research such that people don't have to die from this preventable disease.
An investigator in the Phase I/II trial of Amgen's AMG 510 said that while data for colorectal cancer indicated low activity as a single agent, it nevertheless represented a doubling in progression-free survival over what is seen from currently available treatments.
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Although they're still early, the company presented Phase Ib/II study data showing its PLK1 inhibitor, onvasertib, was able to produce responses in KRAS-mutated metastatic CRC, through a property known as synthetic lethality. KRAS-specific drugs have shown low efficacy in mCRC.
The companies tout the deal as expanding Exact's commercial footprint to 90 countries and creating a leader in the cancer diagnostic space with projected 2020 revenues of $1.6 billion.
The South San Francisco company intends to use the funding to launch its pivotal trial for its blood-based colorectal cancer screening and submit its test for parallel review for CMS coverage.
The deal includes an upfront payment and up to 100 million euros in milestones, equaling $364.5 million. Amal's lead candidate is a vaccine for colorectal cancer expected to enter the clinic later this month.
Several patients in the trial of CYAD-101 combined with chemotherapy responded to treatment, but both a company executive and a gastrointestinal cancer expert cautioned the data were too preliminary to draw conclusions.