Noted This Week
Bristol-Myers Squibb announced that the FDA approved the monoclonal antibody elotuzumab (Empliciti) in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least two prior therapies. The approval was based on the phase II ELOQUENT-3 trial, in which patients treated with the drug cocktail had a median progression-free survival of 10.3 months and an overall response rate (ORR) of 53%, compared with 4.7 months and 26% in patients who received pomalidomide and dexamethasone. Elotuzumab was previously approved for the same disease in combination with lenalidomide and dexamethasone.
The agency also granted an accelerated approval to the ALK inhibitor lorlatinib (Lorbrena; Pfizer) for patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease worsens after other therapies. Approval was based on a phase I/II trial in which 215 patients had an ORR of 48% and an estimated median duration of response of 12.5 months; 89 patients with brain metastases had an ORR of 60%. This is the first FDA approval for lorlatinib.
Coherus BioSciences announced that the FDA approved pegfilgrastim-cbqv (Udenyca), a biosimilar of pegfilgrastim (Neulasta; Amgen). The drug decreases the risk of infection in patients with nonmyeloid cancer who are receiving chemotherapy and have febrile neutropenia. The agency approved pegfilgrastim-jmdb (Fulphila; Mylan), the first biosimilar of pegfilgrastim, in June.
Novartis announced that it will no longer pursue FDA approval of GP2013, a biosimilar of rituximab (Rituxan; Genentech). The decision comes after the FDA declined to approve the CD20 inhibitor in May without additional information. The drug has been approved by the European Commission and in Switzerland, Japan, New Zealand, and Australia for certain forms of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and various immune diseases.
Global melanoma mortality rates are increasing among men but steady or decreasing among women, according to findings presented at the 2018 National Cancer Research Institute Cancer Conference in Glasgow, UK. Researchers analyzed 3-year average death rates in 33 countries between 1985 and 2015 and found that more men than women died from melanoma in all of the countries; In 32 countries, the mortality rate for men increased.
Janssen agreed to pay Yuhan $50 million up-front for the EGFR inhibitor lazertinib in a deal that could earn the South Korea–based company up to $1.25 billion in milestone payments. The drug is being developed as a therapy for EGFR-mutated NSCLC, and it may shrink metastases in the brain. Janssen and Yuhan will collaborate on trials testing lazertinib alone and in combination with other therapies.
Illumina will acquire Pacific Biosciences for $1.2 billion. With the deal, Illumina will add PacBio’s long-read sequencing technology to its own short-read sequencing platforms. The acquisition will also broaden Illumina’s portfolio to include de novo assembly of plant and animal genomes, functional genomics, tissue transplantation, and pharmacogenomics.