The FDA granted priority review status to Enhertu (DS-8201) for the treatment of patients with HR-positive, low HER2-expressing breast cancer, and Enhertu has enabled these patients to remain disease-free for an average of 10.1 months, with an average overall survival time of nearly two years. A decision on approval is expected to be made in the fourth quarter of this year.
The US FDA has approved pemigatinib, the first targeted drug to date for patients with specific mutated blood tumours, and the results of the study show that the drug made tumours disappear completely in 79% of patients!
Data from a study presented at the annual meeting of the European Society of Medical Oncology in 2022 showed that lenvatinib in combination with Pembrolizumab could give 100% efficacy in this group of patients.
A study at Massachusetts General Hospital in the US demonstrated that Adagrasib alone and in combination with cetuximab delivered good results in patients with advanced colorectal cancer with KRAS G12C mutations, with 46% of subjects experiencing substantial tumour shrinkage and an efficacy rate of 100%.
Targeted drug Selpercatinib has received accelerated approval from the FDA. It is cancer-independent and may benefit any solid tumour with a positive RET gene fusion. It is up to 84% effective in selected patients with non-small cell lung cancer!
The results of a new study show that Ubamatamab, a bispecific antibody drug, has shown excellent results and a good safety profile in patients with ovarian cancer.
DZD1516 is a reversible, selective HER2-targeting agent with full blood-brain barrier penetration. It has demonstrated good therapeutic response in phase I studies in patients with metastatic HER2-positive breast cancer, including breast cancer patients with central nervous system metastases.
Recently, the US FDA has granted orphan drug status to two new therapeutics in a row. One is a small molecule inhibitor, PCLX-001, for the treatment of acute myeloid leukaemia; the other is a T-cell therapy, ET140203, for the treatment of hepatoblastoma. Both therapies are currently in relevant trials.
On November 4, 2022, the U.S. FDA has approved the marketing of mivituximab soratansine (Elahere), a cutting-edge antibody-coupled drug targeting folate receptor alpha (FRα), for the treatment of adult patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three systemic treatment regimens and are folate receptor alpha (FRα)-positive and platinum-resistant.
A new clinical trial update shows that oxitinib (known as Teresa, or 9291) nearly doubled disease-free survival and halved post-operative recurrence rates in lung cancer patients carrying an early stage EGFR mutation!
