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!
The US FDA approved the ADC drug gosatumumab (Trodelvy) for the treatment of patients with hormone receptor-positive, HER2-negative breast cancer. In the trial, the drug significantly extended the overall survival of patients and reduced the risk of death by 21%.
Recently, the frontier drug INT230-6 showed good tumour killing effects in the treatment of soft tissue sarcoma in the single arm phase 1/2 open-label clinical trial IT-01 (NCT03058289), and the drug showed good responses whether injected inside the tumour alone or in combination with the CTLA-4 immune checkpoint inhibitor ipilimumab.
A three-drug combination regimen significantly prolongs survival in patients with HPV-positive cancers, new data from a clinical trial shows. For patients who had not been treated with immune checkpoint inhibitors, it resulted in significant tumour shrinkage in 88% of patients, and even in patients who failed immune checkpoint inhibitor treatment, 63% had significant tumour shrinkage.
A new generation of oral selective estrogen receptor degrader, elastostat, has shown promise in clinical studies over standard second-line treatments such as fulvestrant for the treatment of patients with metastatic hormone receptor-positive breast cancer.
The results of a new study recently showed that Olutasidenib monotherapy in patients with relapsed/refractory acute myeloid leukaemia carrying the IDH1 mutation elicited high rates of complete remission with manageable toxicity.
The US FDA has approved a new leukaemia drug, Olutasidenib, which has been shown to be effective and has a controlled safety profile, resulting in the complete disappearance of cancer cells in 35% of patients enrolled, with efficacy lasting up to 25.9 months.
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