Cyramza (ramucirumab) gain a 6th FDA-approved oncology indication
… Lilly continues to successfully grow its oncology product portfolio …


Lilly continues to build out its oncology brand pharmaceutical franchise with new Cyramza indications

John G. Baresky

The U.S. Food and Drug Administration (FDA) has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Erlotinib is the generic form of the original Genentech/Roche brand product Tarceva.

Cyramza widens market access and revenue streams with new indication

This latest of six FDA-approved cancer treatment indications for Cyramza will be well received by those oncologists, pulmonologists and other medical professionals involved with the treatment of lung cancer patients. Cyramza’s other oncology indications span specific types of colorectal, liver, lung and stomach cancer.

A 6th indication gives Cyramza a wider footprint in managed care organizations and other payer formularies which fortifies its market access position. The NSCLC market sector has approximately 70 oncology therapies vying for business through their brand and generic pharmaceutical manufacturers. With an FDA-approved indication in this category they are now more eligible to promote it and create an additional revenue stream.

Available by prescription only, Cyramza is a fully human monoclonal antibody (mAb) that is administered via IV infusion. Lilly already has a very successful mAb therapy on the market. Launched in 2016, Taltz (Ixekizumab) is used to treat a variety of autoimmune diseases. Over the course of 2019, it produced over $1.3 billion in sales.

Clinical information about NSCLC

Over 80% of the lung cancer cases diagnosed are NSCLC. NSCLC has three main subtypes that start with different cell types but are bundled together as they have similar treatments and expected outcomes:

  • Adenocarcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma

Cyramza continues to grow as an oncology brand pharmaceutical franchise

Cyramza was initially launched in 2014. It originated in the pipeline of ImClone Systems, a Bridgewater, New Jersey company that Lilly acquired in 2008 for $6.5 billion in a highly competitive bidding duel with oncology powerhouse Bristol Meyers Squibb (NYSE: BMY).

Genentech’s Tarceva earned its first FDA approval in 2004. The product went generic in 2014. Genentech, based in South San Francisco, is a wholly-owned subsidiary of Roche AG based in Basel, Switzerland. Like Lilly, Roche (Swiss Exchange: ROG-CH OTCQX: RHHBY) is a global leader in the development of advanced medicine and generated about $64 billion in sales during 2019.

Eli Lilly is having a banner year in 2020

Lilly has cultivated a robust oncology portfolio including its latest new product, Retevmo (selpercatinib), which was approved for 3 separate cancer indications in May 2020. Lilly achieved another win in May 2020 with the FDA approval of its new Alzheimer’s diagnostic IV drug Tauvid (flortaucipir F18). The latest new indication for Cyramza extends their streak of good fortune. There is no doubt Lilly is looking forward to exceeding their 2019 sales that were approximately $22.3 billion.

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