Approvals

FDA approves Imbruvica combo for treatment-naive CLL patients

Johnson & Johnson (J&J) and AbbVie have secured approval from the US Food and Drug Administration (FDA) for Imbruvica plus obinutuzumab as non-chemotherapy combination regimen for treatment- naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

EC approves Clovis’ Rubraca to treat women with relapsed ovarian cancer

Clovis Oncology has secured approval from the European Commission (EC) for its Rubraca (rucaparib) as maintenance treatment for women with relapsed ovarian cancer.

EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL

Amgen announced that the European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.

EC approves Vertex’s CF treatment Orkambi for children aged two to five years

Vertex Pharmaceuticals (Europe) has secured approval from the European Commission (EC) for Orkambi (lumacaftor/ivacaftor) to treat of children with cystic fibrosis (CF) aged two to five years old who have two copies of the F508del mutation.

Exelixis announces US FDA approval of CABOMETYX tablets for previously treated HCC

Exelixis announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Novartis gets breakthrough therapy status for sickle cell disease treatment crizanlizumab

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for crizanlizumab (SEG101) to prevent vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).

BMS’ Sprycel secures FDA approval to treat pediatric Ph+ ALL

The US Food and Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients, aged one year or more.

US FDA approves Sanofi’s new pediatric vaccine

The US Food and Drug Administration (FDA) has approved Sanofi’s pediatric hexavalent combination vaccine for use in children between six weeks and five years of age.

FDA accepts Kala Pharmaceuticals’ NDA for KPI-121 0.25%

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by Kala Pharmaceuticals for its KPI-121 0.25% product candidate.