Lilly's Cyramza closer to first-line lung cancer use after ODAC verdict

Eli Lilly’s cancer drug Cyramza has inched closer to a new indication in first-line non-small cell lung cancer (NSCLC), after a narrow vote in favour of approval by FDA advisors.

The 6-5 vote by the Oncologic Drugs Advisory Committee (ODAC) concluded that the combination of Cyramza (ramucirumab) with Roche’s Tarceva (erlotinib) should be approved by the FDA for previously-untreated patients with EGFR-positive NSCLC

The ODAC concluded that the combination demonstrated a favourable benefit/risk profile overall thanks to data from the RELAY trial showing an improvement in progression-free survival when Lilly’s drug was added to Tarceva.

VEGF inhibitor Cyramza adds another weapon to the arsenal in these patients, but a lack of overall survival data – and also the possibility that survival may even be slightly worse with the combination – resulted in the sizeable block of ‘no’ votes.

In RELAY, Cyramza improved the time patients lived without their cancer growing or spreading after starting treatment by seven months compared to placebo when added to Tarceva therapy – extending PFS to 19.4 months from 12.4 months.

The trial is continuing until it is mature enough to give a readout on overall survival, according to Lilly.

The FDA now has to decide whether to approve the drug based on the data, and that could be too close to call.

In a briefing document published ahead of the ODAC meeting, the agency notes that there is a need for new first-line treatments for EGFR-positive NSCLC, but also that “there are therapies currently approved for which an improvement in overall survival has been observed when compared to first generation EGFR [drugs].”

While additional treatment options are always welcome, panellists expressed reservations about the increase toxicity burden when Cyramza was added to Tarceva, and data suggesting patients’ quality of life wasn’t improved by the combination.

Cyramza is already approved to treat four different cancer types, including second-line lung cancer and gastric, liver and stomach cancers, and is knocking on the door of blockbuster status with sales reaching $925 million last year.

Approval in first-line NSCLC would be a sizeable step up for the drug in terms of eligible patient population, although it will face significant competition from AstraZeneca’s EGFR inhibitor Tagrisso (osimertinib), which was approved for first-line use in this setting in 2018, as well as other drugs in the EGFR class.

Meanwhile, there was disappointment at the ODAC for Luxembourg biotech Steba after the panel voted 13-2 not to support approval of its laser-activated therapy Tookad VTP (padeliporfin di-potassium) for low-risk, localised prostate cancer.

The committee took issue with a number of the elements in Steba’s marketing application, including the design of its pivotal trial and missing data, and also adverse events linked to the treatment.