Denosumab appears to have a neutral effect on the risk of composite and specific cardiovascular outcomes among patients with primary osteoporosis, whereas romosozumab may contribute to an increased risk of four-point major adverse cardiovascular event, according to the results of a meta-analysis.
First-line treatment with durvalumab + platinum-etoposide (EP)* improves overall survival (OS) in Asian patients with extensive-stage small-cell lung cancer (ES-SCLC), according to the CASPIAN** study.
Oral form of the GLP-1* analogue semaglutide was superior to the SGLT-2i** empagliflozin in reducing HbA1c in patients with type 2 diabetes (T2D) uncontrolled on metformin, according to the head-to-head PIONEER 2*** trial.
Use of fludarabine cytarabine and granulocyte colony stimulating factor with or without idarubicin (FLAG ± IDA) leads to a 69-percent rate of complete remission in children with relapsed/refractory acute leukaemia, but only 48 percent of patients survive to bone marrow transplantation, a study has shown.
There appears to be no significant survival difference between first-line immune checkpoint inhibitor (ICI) and carboplatin-based chemotherapy in cisplatin-ineligible metastatic urothelial carcinoma patients, according to a Taiwan study presented at the recent 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
Concurrent treatment with acid suppression therapy and capecitabine in colorectal cancer patients seems to result in decreased progression-free survival, with a trend towards lower overall survival, according to a study.
New drug applications approved by US FDA as of 16 - 30 November 2018
which includes New Molecular Entities (NMEs) and new biologics. It does
not include Tentative Approvals. Supplemental approvals may have
occurred since the original approval date.
Five years of extended therapy with the aromatase inhibitor (AI) letrozole did not improve survival in postmenopausal breast cancer patients, according to findings of the NRG Oncology/NSABP B-42 trial presented at the San Antonio Breast Cancer Symposium (SABCS 2016) held in Texas, US.
Adding everolimus to fulvestrant in second-line treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer improves progression-free survival (PFS) by 40 percent, the phase II PrECOG 0102 study has shown. [SABCS 2016, abstract S1-02]