If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
With this, the company has secured 511 marketing approvals for its oncology products across 66 countries
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
For people with relapsed or refractory diffuse large B-cell lymphoma
The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
It is the first autotaxin inhibitor to be investigated in cancer patients
Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA
Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient
Subscribe To Our Newsletter & Stay Updated
