FDA approves Pfizer’s ALK-positive non-small cell lung cancer drug


American pharmaceutical giant- Pfizer has reportedly announced that the U.S. Food and Drug Administration (FDA) has sanctioned the use of a supplemental NDA (new drug application) for Lorbrena or lorlatinib, that expands the indication of the drug to include the treatment for patients diagnosed with anaplastic lymphoma kinase- positive non-small cell lung cancer. As per a statement by the company, the development updates on FDA’s previously accelerated approved for the drug in the year 2018. Lorbrena is designated for adults suffering from metastatic non-small cell lung cancer with ALK-positive tumors. Andy Schmeltz, Global President, Pfizer Oncology, was reportedly quoted stating that Lorbrena has emerged as a transformative medication for patients with ALK-positive non-small-cell lung cancer and the FDA approval marks the first reliable treatment solution in this field. As an ALK inhibitor, Lorbrena helps prevent common tumor mutations by increasing the body’s resistance to certain medicines that may lead to metastases to the brain. Nearly 40% of the patients suffering from ALK-positive non-small cell lung cancer have brain metastases once they receive a diagnosis. For the record, the expanded approval of the drug was based on the results from a phase CROWN trial, that comprised 296 people who were untreated for cancer. 149 patients were given Lorbrena while 147 of them were given Xalkori. Lorbrena helped lower the risk of disease progression or death by approximately 72% when compared to Xalkori. In addition to the above, the trial included candidates with brain metastases in the Lorbrena and the Xalkori groups. Patients given Lorbrena showcased a higher intracranial objective response rate when compared to those assigned Xalkori. Citing sources, the CROWN trial study has concluded that Lorbrena can help significantly enhance the outcomes during the first-line treatment of ALK-positive non-small cell lung cancer along with those with brain metastases. Source Credit: https://www.curetoday.com/view/fda-approves-lorbrena-as-first-line-treatment-for-alk-positive-non-small-cell-lung-cancer