Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
The Phase 3 SOLO-1 trial demonstrated 67% of advanced ovarian cancer patients with BRCA mutations receiving LYNPARZA were alive at seven years versus 47% of placebo patients
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.
First and only PARP inhibitor to improve invasive disease-free survival in patients
If approved, Tafinlar + Mekinist may offer a potential new standard-of-care for pediatric patients with this brain cancer
Scemblix (asciminib) continues to show superior efficacy with more-than-two-fold improvement in major molecular response rate vs. Bosulif (bosutinib) at 96 weeks
he Phase 2 TIDAL data generated to date continue to highlight zandelisib's therapeutic profile and the potential to benefit patients
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