Roche, AbbVie, AstraZeneca, Amgen Lead Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche, AbbVie, AstraZeneca, and Amgen.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 6, 2018 date to Tuesday June 12, 2018.
FDA OKs New Use for Roche’s, AbbVie’s Cancer Drug Venclexta in Combination with Rituxan
The US Food and Drug Administration (FDA) has approved Roche’s Venclexta (venetoclax), a leukemia drug, in combination with Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases, for treating people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
Venclexta is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the US and commercialized by AbbVie outside of the US.
This FDA combination approval converts Venclexta’s previous accelerated approval to a full approval. Venclexta was granted accelerated approval in April 2016 as a single agent for treating people with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA has also updated the indication for Venclexta as a single agent, which is now approved for treating people with CLL or SLL, with or without 17p deletion, who have received at least one prior therapy.
EC OKs New Use for AstraZeneca’s Lung Cancer Drug Tagrisso
The European Commission has granted marketing authorization for a new use for AstraZeneca’s Tagrisso (osimertinib) as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
The approval follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
In the EU, Tagrisso is already indicated for treating patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. This newest approval follows the recent approvals of Tagrisso for the first-line treatment of patients with metastatic EGFR-mutated (EGFRm) NSCLC in the US, Brazil, and the Russian Federation. Tagrisso is also under regulatory review in Japan for use in the first-line treatment setting with a decision anticipated in the second half of 2018, with other global health authority reviews and submissions ongoing.
EC Approves New Use for Amgen’s Osteoporosis Drug Prolia
The European Commission (EC) has approved a new indication for Amgen’s Prolia (denosumab) for treating bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
In the EU, Prolia is also approved for treating bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia is designed to reduce the risk of vertebral fractures, according to information from Amgen. Prolia is also approved in the EU for treating bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
The US Food and Drug Administration approved the expanded indication of Prolia for treating osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy in men and women at high risk of fracture in May 2018.
Prolia is also approved in the US for treating postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or in patients who have failed or are intolerant to other available osteoporosis therapy. Prolia is also approved for treatment to increase bone mass in men with osteoporosis at high risk for fracture. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer in the US.