Biomarker driven segments of NSCLC - Yet to saturate with new approvals


  • Industry experts think that NSCLC space is rushed with so many approvals, yet it is a hot space for researchers, as NSCLC market has huge potential and even 1% market share is a piece of hot cake for the investors.
  • Currently, there are a total of 5 FDA-approved TKIs for frontline treatment in EGFR- positive NSCLC.
  • Though, recent data on frontline Osimertinib confers the greatest progression-free survival (PFS) advantage for patients with EGFR-positive non–small cell lung cancer (NSCLC)
  • Experts indicated that they would look forward to the novel approaches that are trying to enhance the activity of Osimertinib by targeting other oncogenic pathways in combination with anti-EGFR therapy.

Chemotherapy is backbone to treat many types of cancers, and research continues to find new chemotherapy regimens in combination with novel drugs. Over a decade, NSCLC space has evolved immensely.

Even though NSCLC space has been bifurcated into many biomarker driven patients segment with specific approval in these segments, still in upcoming years we will see more approvals in the space. Industry experts think that this space is rushed with so many drugs, yet it is a hot space for researchers, as NSCLC is a huge market and even a single percent market share is a piece of hot cake for the investors.

Currently there are a total of 5 FDA-approved TKIs for frontline treatment of EGFR- positive NSCLC. These include erlotinib (Tarceva), gefitinib (Iressa), afatinib (Gilotrif), Dacomitinib (Vizimpro), and Osimertinib (Tagrisso).

We have seen a lot of exciting data over the past couple years with regard to these agents as monotherapy or in combination. Despite the sequential efficacy of these FDA-approved EGFR TKIs, frontline Osimertinib confers the greatest progression-free survival (PFS) advantage for patients with EGFR-positive non–small cell lung cancer (NSCLC) recently.

Therefore, we still expect to see several studies moving forward with results reported out in the coming years. We expect an emergence of new biomarker driven segments also (for e.g., Novel combinations, certainly targeting VEGF or MET).

There are exciting ongoing studies targeting MET following progression on Osimertinib. Experts indicated that they would look forward to the novel approaches that are trying to enhance the activity of Osimertinib by targeting other oncogenic pathways in combination with anti-EGFR therapy.