Under new pressure from Roche's Alecensa, Pfizer's Xalkori has picked up two FDA breakthrough designations, one for certain lung cancer patients and another in a rare form of lymphoma.
Xalkori won FDA breakthrough-therapy designations in metastatic NSCLC with MET exon 14 alterations, as well as for patients with ALK-positive relapsed or refractory systemic anaplastic large cell lymphoma, the drugmaker said in a release.
MET 14 alterations occur in about 3% of NSCLC cases, Pfizer says, while anaplastic large cell lymphoma cases make up 2% of non-Hodgkin lymphomas.
The FDA grants breakthrough designations for drug candidates that treat serious and life-threatening diseases when data demonstrate they can significantly improve patient care over existing options. The program is designed to speed up the regulatory process.
If approved in the indications, Xalkori would have two new growth avenues as it comes under threat from Roche's Alecensa in ALK-positive non-small cell lung cancer. In November, Alecensa picked up a first-line nod for the patient group, stepping up to challenge Xalkori and Novartis' Zykadia. Novartis' med won its approval in the indication in May 2017.
Alecensa boasts Xalkori-besting data that Dietmar Berger, Roche’s global head of clinical development in hematology and oncology, previously said will make it "the new standard of care for first-line" treatment. In a phase 3 trial, Roche reported that median progression-free survival was 25.7 months for Alecensa patients, compared with 10.4 months for Xalkori patients.
Alecensa cut the risk of disease worsening or death by 47% compared to Xalkori, according to Roche.
The breakthrough designations further demonstrate how oncology is shifting into increasingly targeted biomarker identification and treatment, boosting patient outcomes. In a statement, Pfizer oncology chief development officer Mace Rothenberg said the designations "exemplify our commitment to precision medicine development and delivering medicines that have the potential to transform the lives of patients whose cancers carry these genomic alterations.”
Xalkori pulled in $594 million last year, or 6% growth from 2016.