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Roche's lung cancer drug Alecensa wins EU approval

Roche's lung cancer drug Alecensa wins EU approval
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Sandra Horning , Roche Alecensa , European Commission ,

Pfizer (PFE) Lorviqua Gets EU Nod for First-Line Lung Cancer

The European Commission approves label expansion of Pfizer's (PFE) Lorviqua as a first-line treatment for ALK-positive non-small cell lung cancer. ....

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Nuvalent bags $135M to trial resistance-beating kinase inhibitors in lung cancer

May 11, 2021 7:00am
Nuvalent will use the money to fund clinical development of its parallel lead programs, NVL-520 and NVL-655. (Robina Weermeijer/Unsplash)
Nuvalent has raised $135 million to take ROS1 and ALK kinase inhibitors into the clinic. The series B, which comes months after Nuvalent disclosed a $50 million round, sets Nuvalent up to study drugs designed to improve on products such as Roche’s Alecensa and Pfizer’s Xalkori.
Kinase inhibitors have improved cancer outcomes by binding to enzymes that drive the proliferation, survival and metastasis of tumors. However, changes to the binding sites lead to resistance, creating a need for treatments that are effective in patients who stop responding to existing drugs. Nuvalent is working to deliver those treatments. ....

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Pfizer's ALK inhibitor Lorbrena scores expanded FDA approval for first-line NSCLC

Pfizer’s ALK inhibitor Lorbrena scores expanded FDA approval for first-line NSCLC
The European Medicines Agency is also reviewing an application for the drug
The US Food and Drug Administration (FDA) has approved a new indication for Pfizer’s Lorbrena in the first-line treatment of metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
The expanded approval is based on the phase 3 CROWN trial, which demonstrated that Lorbrena (lorlatinib) reduced the risk of disease progression or death by 72% in metastatic ALK-positive NSCLC patients compared to Xalkori (crizotinib).
In addition, Lorbrena also showed benefit in patients with central nervous system involvement. There were 17 patients in the Lorbrena arm and 13 in the Xalkori arm with measurable brain metastases based on baseline imaging. ....

Novarti Zykadia , Andy Schmeltz , Roche Alecensa , Merck Co Keytruda , European Medicines Agency , Drug Administration ,

Pfizer's Lorbrena breaks into front-line ALK lung cancer, jostling with Novartis, Roche and Takeda

Mar 4, 2021 10:54am
The FDA has expanded Pfizer s Lorbrena approval to include front-line ALK-positive non-small cell lung cancer.
Pfizer’s Lorbrena has finally broken into front-line non-small cell lung cancer, where Novartis, Roche and Takeda are already jockeying for a niche market.
The FDA expanded Lorbrena’s use into newly diagnosed patients with ALK-positive NSCLC, Pfizer said Wednesday. With that front-line nod, the agency converted Lorbrena s conditional green light for previously treated cases into a full approval.
How does Pfizer expect to compete in such a crowded field? As a third-generation ALK inhibitor, Lorbrena has arguably the best efficacy data in head-to-head tests against its predecessor, Xalkori. ....

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