"Drug"

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.

The US FDA has approved pablizumab (Keytruda) as an adjuvant treatment for early-stage non-small cell lung cancer. In the trial, pablizumab (Keytruda) significantly prolonged cancer-free survival in patients compared to placebo.

Recently, a study for the treatment of advanced EGFR-mutated and c-MET-positive lung cancer showed good results with the cutting-edge ADC drug teliso-V in combination with the EGFR generation-targeted drug troche (i.e. erlotinib).

Many lung cancer patients will be detected by genetic testing to carry an EGFR mutation, and these patients can often control their tumours with EGFR-targeted drugs. Although targeted drugs are effective and have fewer side effects than chemotherapy, resistance to them inevitably occurs, after which they no longer work.

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.

Bile duct cancer is a rare but highly malignant tumour that occurs in the human bile duct system and has long had a poor prognosis. Now, researchers at University College London and University College London Hospitals, in an international multi-centre trial, have identified potentially good treatments that may radically improve the lives of some patients with bile duct cancer.

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 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 US FDA has approved Elacestrant, the first oral selective estrogen receptor degrader (SERD), for the treatment of patients with advanced or metastatic breast cancer who are estrogen receptor positive, HER2 negative and have an ESR1 mutation. Results of the trial showed that patients treated with Elacestrant had a 45% reduction in the risk of disease progression or death.