An approval from the U.S. FDA doesn’t guarantee a green light overseas—a lesson Mirati Therapeutics has learned the hard way after European regulators rebuffed the company’s flagship KRAS inhibitor Krazati. Friday, Mirati revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had spurned the company’s conditional marketing authorization application for Krazati, also known as adagrasib, to treat patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). In a release, Mirati said it “disagrees with the opinion” and intends to file for a formal re-examination. Once considered an undruggable target, KRAS now has two FDA-approved therapies competing in a potential blockbuster cancer market in the United States. After Amgen won an accelerated nod for its rival KRAS inhibitor Lumakras in May 2021, Mirati entered the fray with Krazati—the biotech’s first commercial product—in December. While Amgen’s drug has suffered a sequential sales decline in the U.S., Mirati’s med recently surprised ...
Glioblastoma (histology slide). Credit: Wikipedia/CC BY-SA 3.0 “Don’t eat me,” is how one might translate the signal that the cancer cells in a glioblastoma send to the macrophages (white blood cells specialized in removing dead and dying cellular matter) in the brain. Immunotherapy attempts to enable these cells to eradicate the abnormal cells, but so far, it has met with little success when it comes to glioblastomas. Researchers led by Professor Gregor Hutter from the Department of Biomedicine at the University and University Hospital Basel have recently used patient data, experiments with mice, and samples from human tumors to study one of these “don’t eat me” signals and its inhibitory effect. Their findings, which may pave the way for effective immunotherapies for glioblastomas, are now being published in Science Translational Medicine. The signal is based on sugar molecules called sialic acid glycans on the surface of the cancer cells. These sugar molecules are ...
Pfizer’s JAK inhibitor Xeljanz reduced the risk of severe outcomes in hospitalised adult patients with COVID-19 pneumonia who were not on ventilation, according to new study data. The STOP-COVID trial was conduction by Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paolo, Brazil, which was also the trial coordinating centre. Patients were randomised to receive either Xeljanz (tofacitinib) 10mg twice daily plus standard of care (SoC) or placebo twice daily plus SoC for up to 14 days or until hospital discharge. The trial demonstrated a reduced cumulative incidence of death or respiratory failure through day 28 with Xeljanz (18.1%) compared to placebo (29.9%). In addition, death from any cause occurred in 2.8% of Xeljanz-treated patients compared to 5.5% in the placebo group. In the study, serious adverse groups occurred in 14.1% of patients in the Xeljanz group and 12% in the placebo group. Protocol-specified adverse events ...
GlaxoSmithKline’s (GSK) PD-1 inhibitor Jemperli has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of recurrent or advanced endometrial cancer. Specifically, Jemperli (dostarlimab) has been granted a conditional marketing authorisation for use in adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer, who have progressed on or following prior treatment with a platinum containing regimen. The authorisation is based on results from the open-label GARNET study, which included women with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed on or after a platinum-based chemotherapy regimen. Jemperli treatment led to an objective response rate of 44.8% and a disease control rate of 57.1%, while a median duration of response (DoR) had not been reached in these patients. However, the probability of maintaining a response at six months and 12 months was 97.9% and 90.9% respectively, according to ...
U.S. based public biotechnology company, Assembly Bioscience revealed the launch of two randomized control phase 2a trials for its leading hepatitis B core inhibitor in a press release.
New collaboration to explore the potential clinical benefits of two novel and complementary immuno-oncology mechanisms
The EMA has kicked off its review of Sanofi and Regeneron’s immuno-oncology drug cemiplimab, which is aiming to become the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market.
Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that it has commenced dosing of its small molecule inhibitor of RIPK1 in a Phase 1 clinical trial in healthy volunteers and achieved proof of concept of its large molecule blood-brain barrier delivery platform technology in nonhuman primates.
Cancer cells are different from normal cells in that they can avoid a naturally programmed cell death process known as apoptosis and grow almost indefinitely. In their third collaboration, Boehringer Ingelheim and Vanderbilt University have their eyes on a target that helps cancer cells evade death.
Cancer Research UK is partnering with US biotech Ideaya Biosciences to develop small molecule inhibitors of Poly(ADP-ribose) glycohydrolase (PARG).
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