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Original New Drug Application Approvals by US FDA (16-30 June 2024)

15 Jul 2024

New drug applications approved by US FDA as of 16-30 June 2024 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.

15 Jul 2024

Ivonescimab plus chemo confers progression-free survival advantage in pretreated NSCLC

14 Jul 2024

Ivonescimab plus chemotherapy has a tolerable safety profile and appears to significantly prolong progression-free survival (PFS) in patients with nonsmall cell lung cancer (NSCLC) whose disease progressed while receiving EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, according to interim data from the phase III HARMONi-A study.

14 Jul 2024

NATALEE update: Ribociclib + NSAI well tolerated

12 Jul 2024 bởi

Latest findings from the ongoing phase III NATALEE trial have shown that 3-year treatment with adjuvant ribociclib, in combination with a nonsteroidal aromatase inhibitor (NSAI), remained well tolerated in patients with HR+/HER2- early-stage breast cancer (EBC).

12 Jul 2024

Osimertinib extends PFS by 3.2 years in LAURA

12 Jul 2024 bởi

Osimertinib extends progression-free survival (PFS) sevenfold longer than placebo in patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC) following definitive chemoradiotherapy, as shown in the primary analysis of the phase III LAURA study presented at ASCO 2024. This breakthrough makes osimertinib the first EGFR inhibitor to show benefit in a stage III setting.

12 Jul 2024

DESTINY-Breast03 reports longest OS in previously treated HER2-positive mBC

12 Jul 2024 bởi

Long-term follow-up of the DESTINY-Breast03 trial has reported a median overall survival (OS) of 52.6 months with trastuzumab deruxtecan (T-DXd), representing the longest reported OS in previously treated HER2-positive metastatic breast cancer (mBC) to date.

12 Jul 2024

Body size may affect cancer prognosis

11 Jul 2024

Body size appears to have an impact on the prognostic outcomes in patients with cancer, reveals a study. Both hand grip strength (HGS) and subcutaneous fat affect the influence BMI has on such prognosis.

11 Jul 2024