Eugene Manley, Jr., PhD, LCRF’s Director of Scientific Programs, compiled the following list of FDA drug approvals for lung cancer treatment taking place in 2021. The associated companion diagnostics have been included where applicable. “Companion diagnostics are devices, tests, or imaging tools that provide information essential to the use of the therapeutic product,” Dr. Manley explained. “In general, they are associated with detecting mutations and are necessary for optimally selecting treatment for patients.”

Approvals are listed in date order. Download a PDF chart

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Feb 3

Tepotinib (Tepmetko®; Merck KGaA/EMD Serono) approved for MET exon 14 skipping metastatic non-small cell lung cancer (NSCLC); given orally

  • Trial: phase 2 VISION
Feb 22

Cemiplimab-rwlc (Libtayo®; Regeneron and Sanofi) approved for advanced NSCLC (locally advanced, not resection candidates or definitive chemoradiation or metastatic), with high PD-L1 expression with no EGFR, ALK, or ROS1 aberrations; monoclonal antibody given intravenously

  • Trial: phase 3 EMPOWER – Lung 1
March 3

Lorlatinib (Lorbrena®; Pfizer) approved for ALK+ metastatic NSCLC not receiving prior systemic therapy for metastatic disease; given orally

  • Trial: phase 3 study B7461006
  • Companion diagnostic: Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems)
May 21

Amivantamab-vmjw (Rybrevant®; Janssen Biotech) approved for EGFR exon 20+ locally advanced or metastatic NSCLC progressing on or after platinum-based chemo; bispecific EGFR and MET antibody given intravenously

  • Trial: phase 2 CHRYSALIS
  • Companion diagnostic: Guardant360® CDx (Guardant Health, Inc.)
May 28

Sotorasib (Lumakras; Amgen) approved for KRAS G12C+ locally advanced or metastatic NSCLC in patients receiving at least one prior systemic therapy

  • Trial: phase 2 CodeBreaK 100
  • Companion diagnostics: therascreen® KRAS RGQ PCR kit (QIAgen) tissue RT PCR diagnostic for KRAS; Guardant360® CDx (Guardant Health, Inc.), plasma liquid biopsy
Sept 15

Mobocertinib (Exkivity®; Takeda) approved for EGFR exon 20 insertion+ locally advanced or metastatic NSCLC with progression on or after platinum-based chemo; given orally

  • Trial: phase 1/2 Study 101
  • Companion diagnostic: Oncomine Dx Target Test (Life Technologies Corporation)
Oct 15

Atezolizumab (Tecentriq®; Genentech) approved as adjuvant treatment following resection and platinum-based chemo for patients with stage II to IIIA NSCLC with PD-L1 > 1% on tumor cells

  • Trial: phase 3 Impower010
  • Companion diagnostic: Ventana PD-L1 (SP263 Assay) (Ventana Medical Systems)