Date: 2017-12-21
Type of information: Granting of the Breakthrough Therapy status
Product name: avelumab in combination with Inlyta® (axitinib)
Compound: avelumab in combination with Inlyta® (axitinib)
Therapeutic area: Cancer - Oncology
Action mechanism:
- tyrosine kinase inhibitor/VEGFR inhibitor/monoclonal antibody/immune checkpoint inhibitor. Avelumab is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth. Pfizer and Merck KGaA are jointly developing avelumab as a potential treatment for multiple types of cancer.
- Axitinib is an oral and selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3.
Company: Merck KGaA (Germany) Pfizer (USA - NY)
Disease: naïve patients with advanced renal cell carcinoma (RCC)
Latest news:
- • On December 21, 2017, Merck KGaA and Pfizer announced that the FDA has granted Breakthrough Therapy Designation for avelumab in combination with Inlyta® (axitinib)* for treatment-naïve patients with advanced renal cell carcinoma (RCC). This is the second Breakthrough Therapy Designation granted to avelumab. The Breakthrough Therapy Designation is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a global Phase Ib study assessing the safety and efficacy of avelumab in combination with Inlyta® for the treatment of treatment-naïve patients with advanced RCC. Updated results from this Phase Ib study were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
- The FDA previously granted avelumab Breakthrough Therapy Designation for the treatment of patients with metastatic Merkel cell carcinoma (mMCC) whose disease has progressed after at least one previous chemotherapy regimen.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
