The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
While the Biden administration continues applauding the savings it claims will be delivered by the first round of Medicare negotiations, many U.S. patients and their families are worried about the cost of the biopharma price-setting program – a cost they measure not in dollars and cents, but in worsening illness and lives that may be lost to a downturn in innovation and an upturn in barriers to access.
TYK Medicines Inc. made a strong debut on the main board of the Hong Kong Stock Exchange (HKSE), raising HK$579 million (US$74.32 million) to commercialize its lead compound, EGFR inhibitor TY-9591, now in pivotal trials in patients with EGFR mutation-positive lung cancer.
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
Even as U.S. lawmakers continue to push back against the rising price of prescription drugs and patients with life-threatening diseases clamor for access to new treatments, the FDA is considering a step that could increase the cost and lengthen the development time of therapies targeting non-small-cell lung cancer and perhaps other solid tumors.
The July 25 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) could impact the future development of immune checkpoint inhibitors, such as Astrazeneca plc’s Imfinzi, to treat patients with non-small-cell lung cancer (NSCLC) both before and after surgery. Although much of the discussion will focus on an sBLA for Imfinzi (durvalumab), the committee will be asked to vote on whether the FDA should require that new trial design proposals for perioperative regimens for resectable NSCLC include adequate within-trial assessment of the contribution of the treatment phase to efficacy results.
Scisparc Ltd.’s Mitocarex Bio Ltd. venture has validated the potential significant involvement of its target SLC25 carrier protein, using non-small-cell lung cancer (NSCLC) cells with diverse genetic backgrounds. Mitocarex used genetic manipulations and 3D spheroid systems, mimicking the main features of human solid tumors, to demonstrate the discovery.
Zymeworks Inc. has received IND clearance from the FDA for ZW-191, the company’s novel folate receptor-α (FRα)-targeted topoisomerase I (TOPO1) inhibitor antibody-drug conjugate (ADC). Clinical development is set to begin this year, with filings to initiate studies outside the U.S. to be made in the second half of this year.
A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial.
CDR-Life Inc. has expanded its pipeline of novel T-cell engagers (TCE) with the addition of CDR-813 and CDR-505. CDR-813 is a highly potent and selective TCE candidate targeting tumors expressing PRAME (preferentially expressed antigen in melanoma) in HLA-A*02:01 patients.
