2024 Chemotherapy Labelling 
Big Molecule Watch
JANUARY 10, 2025
Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone.
Pharmaceutical Business Review
AUGUST 19, 2024
The application for ENHERTU is supported by data from the DESTINY-Breast06 Phase III trial, which was highlighted at the 2024 American Society of Clinical Oncology Annual Meeting. These patients had not received prior chemotherapy for advanced disease and had undergone at least two lines of endocrine therapy in the metastatic setting.
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Express Pharma
AUGUST 2, 2024
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma in adult and paediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
pharmaphorum
JANUARY 23, 2023
The drug achieved an impressive 84% overall survival rate over 18 months in patients with advanced GEA who received it as a first-line therapy in combination with chemotherapy, according to data from the open-label study. The median progression-free survival (PFS) of 12.5 months, with a median duration of response was 20.4
pharmaphorum
MARCH 8, 2022
In the study, Trodelvy (sacituzumab govitecan) met its objective of reducing progression-free survival in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment – including endocrine drugs, CDK4/6 inhibitors and two to four lines of chemotherapy.
pharmaphorum
DECEMBER 5, 2022
The positive news comes after a challenging time for GSK, marked by the withdrawal of its US marketing approval for multiple myeloma therapy Blenrep (belantamab mafodotin) last month, along with the narrowing of the label for PARP inhibitor Zejula (niraparib), as well as a retreat from the cell therapy category.
FDA Law Blog: Biosimilars
JANUARY 18, 2024
Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. chemotherapy-induced), pain, and post-traumatic stress disorder. chemotherapy-induced), and pain. chemotherapy-induced), and pain.
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