News

FDA Approved for the Treatment of Refractory Relapsed Primary Mediastinal Large B-Cell Lymphoma in Adult and Pediatric Patients

Posted on 6.27.2018

FDA Approved for the Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma in Adult and Pediatric Patients

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) is indicated for the treatment of adult and pediatric patients with refractory Read More

First FDA-Approved Indication for KEYTRUDA for a Form of Gynecological Cancer

Posted on 6.25.2018

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the US FDA for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed death ligand Read More

Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer

Posted on 5.29.2018

Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of
Recurrent Ovarian Cancer
• Rubraca is now indicated as maintenance treatment for women with recurrent ovarian
cancer who are in a complete or partial response to platinum-based chemotherapy,
regardless of … Read More

Acalabrutinib

Posted on 11.1.2017

U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.… Read More

Axicabtagene Ciloleucel

Posted on 10.19.2017

U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds … Read More

Nivolumab

Posted on 9.29.2017

On September 22, 2017, the Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.… Read More

Pembrolizumab

Posted on 9.29.2017

On September 22, 2017, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an … Read More

Copanlisib

Posted on 9.26.2017

U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.… Read More

Mvasi

Posted on 9.14.2017

U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.… Read More

Mylotarg

Posted on 9.1.2017

U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged … Read More