Merck & Co., Novartis, and Roche Lead Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Merck & Co., Novartis, and Roche.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, September 20, 2017 to Tuesday, September 26, 2017.

FDA OKs New Use for Merck & Co.’s Keytruda
The US Food and Drug Administration (FDA) has approved a new indication for Merck & Co.’s Keytruda (pembrolizumab), an anti-PD-1 therapy. The new indication is for treating patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.

This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Keytruda is indicated for treating various cancers: metastatic melanoma, non-small cell lung cancer, head and neck cancer, Hodgkin’s lymphoma, urothelial carcinoma, and gastric cancer. Keytruda had 2016 sales of $1.4 billion.

Source: Merck & Co.


Novartis Receives EU OK for New Uses for Leukemia Drug
The European Commission (EC) has approved Novartis’ Rydapt (midostaurin) for two new indications in cancer.

Rydapt is approved for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single-agent maintenance therapy.

Rydapt was also cleared for use as a monotherapy for treating adults with aggressive systemic mastocytosis or systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast-cell leukemia.

The approval applies to all 28 European Union (EU) member states, plus Iceland, Liechtenstein, and Norway. Rydapt represents a targeted therapy for FMS-like tyrosine kinase 3-mutated AML and treatment for three subtypes of SM, collectively known as advanced SM, in the EU.

Source: Novartis


Roche Gets EU OK for Cancer Drug Tecentriq

The European Commission (EC) has approved Roche’s Tecentriq (atezolizumab) for three cancer indications.

The drug was approved as a monotherapy for treating people with locally advanced or metastatic non-small cell lung cancer (NSCLC) after they have been previously treated with chemotherapy regardless of PD-L1 status.

The EC also approved Tecentriq as a monotherapy for treating people with locally advanced or metastatic urothelial carcinoma (mUC) who have been previously treated with a platinum-containing chemotherapy or who are considered ineligible for cisplatin chemotherapy, regardless of PD-L1 status.

Tecentriq is already approved in the US and in several other countries for people with metastatic NSCLC and for people with locally advanced or mUC who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

Source: Roche


Roche Gets EU OK for New Use for Lymphoma Drug
The European Commission has approved a new indication for Roche’s Gazyvaro (obinutuzumab) in combination with chemotherapy followed by Gazyvaro maintenance in people achieving a response in previously untreated advanced follicular lymphoma.

This is the third approval for Gazyvaro in the European Union. It was approved in 2014, in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukemia with comorbidities that make them unsuitable for full-dose fludarabine-based therapy. In June 2016, Gazyvaro was also approved in combination with bendamustine, followed by Gazyvaro maintenance, in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with Roche’s cancer drug, MabThera (rituximab), or a MabThera-containing regimen.

Source: Roche


Roche Gets EU OK for New Use for Inflammation Drug
The European Commission (EC) has approved a new indication for Roche’s Actemra/RoActemra (tocilizumab) for treating giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition.

In May 2017 Actemra/RoActemra was approved for treating GCA by the US Food and Drug Administration and New Zealand’s regulatory agency, Medsafe.

In Europe, Actemra/RoActemra IV and subcutaneous formulations are also approved for use in adult patients with severe, active and progressive rheumatoid arthritis who previously have not been treated with methotrexate. Actemra/RoActemra IV formulation is approved in most major countries for polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older.

Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical, a Tokyo, Japan-headquartered pharmaceutical company, and it has been approved in Japan since April 2005. Actemra/RoActemra is approved in 116 countries.

Source: Roche

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