Approvals

FDA approves Kite’s Car T therapy Yescarta for B-Cell Lymphoma

Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy.

US FDA accepts sBLA for Imfinzi in locally advanced and unresectable NSCLC

AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.

US FDA accepts BMS’ application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma

Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

Roche’s Perjeta regimen secures FDA priority review in breast cancer

The US Food and Drug Administration (FDA) has granted priority review for Roche’s Perjeta in combination with Herceptin and chemotherapy to treat HER2-positive early breast cancer after surgery.

Merck, Pfizer get EC approval for skin cancer drug Bavencio

Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.

Pfizer announces outcome of FDA’s ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery

Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).

Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea

Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.

FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment

The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.

CHMP recommends GSK, Innoviva’s single inhaler triple therapy for COPD

GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.