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In Brief This Week: Eli Lilly, Mirati Therapeutics, Legend Biotech, Personal Genome Diagnostics, Sema4

NEW YORK – Eli Lilly this week said that Health Canada has issued a "notice of compliance with conditions" for selpercatinib (Retevmo) in three molecularly defined lung and thyroid cancer indications. The health regulator granted conditional marketing authorization for selpercatinib as a treatment for RET fusion-positive, adult non-small cell lung cancer patients; for RET-mutant, metastatic or unresectable medullary thyroid cancer patients who are at least 12 years old; and for RET fusion-positive, metastatic thyroid cancer in adults who have received sorafenib (Bayer’s Nexavar) or lenvatinib (Eisai’s Lenvima) and stopped responding to radioactive iodine therapy. 

Health Canada relied on data from the LIBRETTO-001 Phase I/II trial, which the US Food and Drug Administration also used to approve the drug for these indications last year. The conditional authorization pathway in Canada facilitates expedited access to drugs for life-threatening illnesses based on early data from clinical trials, but sponsors must submit confirmatory safety and efficacy evidence to maintain access. Lilly is conducting two Phase III trials to establish the clinical activity of selpercatinib.

The US Food and Drug Administration this week granted breakthrough therapy designation to Mirati Therapeutics' investigational KRAS inhibitor adagrasib for patients with previously treated non-small cell lung cancer whose tumors harbor KRAS G12C mutations. The FDA's designation is based on preliminary results of Mirati's ongoing multi-cohort Phase I/II KRYSTAL-01 trial, which is evaluating adagrasib as a treatment for a variety of KRAS G12C-mutated advanced cancers in addition to NSCLC. According to a statement from Mirati CEO Charles Baum, the firm plans to submit a new drug application for adagrasib during the second half of this year. 

Legend Biotech said this week that it will establish a cell therapy manufacturing facility in Belgium. The new facility, where Legend will manufacture ciltacabtagene autoleucel (Janssen's cilta-cel), is part of a collaboration and licensing agreement between Legend and Janssen focused on developing and commercializing the anti-BCMA CAR T-cell therapy. Regulatory agencies in the US and Europe, among other countries, are currently reviewing cilta-cel as a treatment for relapsed or refractory multiple myeloma. Legend, which has previously established cilta-cel manufacturing facilities in China and New Jersey, expects the Belgium facility to be operational by 2023.

The Access to Comprehensive Genomic Profiling Coalition this week added Personal Genome Diagnostics and Sema4 to its coalition of diagnostics companies, laboratory service providers, and comprehensive genomic profiling industry stakeholders to advocate for broad US health insurance coverage of CGP for patients living with advanced cancer. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.