Fruquintinib for gastric cancer: Will it be approved soon?

Fruzaqla (fruquintinib), also known as Elunate, has been gaining attention outside of China in the last couple of years. First as a treatment for metastatic colorectal cancer ¹. Recently, also as a potential treatment for non-small cell lung cancer (NSCLC).

Gastric cancer patients also have a reason to keep their eye on fruquintinib. The medicine is currently being investigated as a potential second-line treatment for the condition.

Here's everything you need to know about ongoing research, expected approvals, and early access options for fruquintinib as a gastric cancer treatment.

What is fruquintinib approved for?

As of May 2024, Fruzaqla (fruquintinib) is approved in the USA and China to treat adults with metastatic colorectal cancer (mCRC). Specifically, the medicine is intended for those who have had prior chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (if applicable) ².

But how come is fruquintinib potentially relevant to other types of cancer? It has to do with VEGF receptors. As a targeted immunotherapy, fruquintinib inhibits the activity of specific VEGF receptors. These receptors normally play a role in tumor angiogenesis. By inhibiting them, fruquinitinib limits the blood supply to tumor cells. As a result, they cannot grow.

VEGF receptors aren't specific to colorectal cancer. They play a role in other types of cancer, too. That's why the hypothesis that fruquintinib could have a similar effect for other indications is plausible.

But could fruquintinib apply to all types of gastric cancer?

What types of gastric cancer can Fruzaqla treat?

So far, clinical trials have looked at Fruzaqla in the context of treating advanced metastatic gastric cancer. One type specifically is the rare gastroesophageal junction adenocarcinoma (G/GEJ).

How effective is fruquintinib for gastric cancer?

Several clinical trials involving fruquintinib in the treatment of gastric and GEJ cancer have been completed in recent years, mostly within China.

Based on the available reports, below are some notable outcomes.

FRUTIGA study results

In this Phase 3 clinical trial, fruquintinib with chemotherapy was compared against chemotherapy alone. The trial patients had either advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. The reported results were:

• • The median progression-free survival with fruquintinib and chemotherapy was 5.6 months. With chemotherapy alone, it was 2.7 months;
  • The overall survival was 9.6 months with fruquintinib and chemotherapy, as compared to 8.4 months with chemotherapy alone. This difference was not statistically significant;
  • Among ptatients with lymph node metastases and non-diffuse G/GEJ adenocarcinoma, the median progression-free survival was even longer (6.08 months vs 2.7 months with chemotherapy alone);
  • Overall survival among patients with lymph node metastases and non-diffuse G/GEJ adenocarcinoma showed a small statistically significant improvement (9.56 months vs 7.85 months with chemotherapy alone) ⁴.

FRUTINEOGA study

Fruquintinib has a low potential for interaction with other medicines. This makes it a good candidate to combine with other oncological treatments. This is part of the reasoning behind the FRUTINEOGA study design. It combines fruquintinib with chemotherapy and S-1 (SOX) as a potential first-line treatment for locally advanced gastric cancer (including GEJ).

The FRUTINEOGA trial is currently ongoing and expected to finalize in November 2024. Its results will shed some light onto the possibility of using fruquintinib as a first-line treatment for gastric cancer.

When will fruquintinib be approved for gastric cancer?

It's difficult to say. The medicine has been submitted for approval for this indication in China [5]. The submission was based on the FRUTIGA clinical trial results.

The median medicine approval timeline in China is 13.7 months [6]. However, considering that Fruzaqla is already a registered medicine in China (under the name ELUNATE), the approval time for its additional indication may be shorter.

As of May 2024, there are no other open applications for the approval of fruquintinib for gastric cancer. This means that it's unlikely to be available to patients outside China any time soon.

Can my doctor prescribe fruquintinib for gastric cancer?

Technically, they can. Whether they will, depends on your personal situation.

Your doctor has the authority to prescribe a treatment even before it's approved for a specific indication. They can do so if they believe that it could benefit you and/or there are no better treatment alternatives for you. To find out whether fruquintinib may be applicable to you, please discuss with your treating doctor.

What if your doctor prescribes fruquintinib before it's approved for gastric cancer? In that case, our team at Everyone.org can help you buy and import fruquintinib, wherever you are. To get started, have your prescription ready and get in touch with us.

References:

1. FDA Approval of Fruquintinib Expands Later-Line Treatment Options in mCRC. OncLive, 17 November 2023.
2. FDA Approves Fruquintinib for Patients with Refractory Metastatic Colorectal Cancer. European Society for Medical Oncology, 20 November 2023.
3. Fruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA). American Society for Clinical Oncology, Accessed 08 May 2024.
4. Second-Line Fruquintinib Plus Paclitaxel Significantly Improves PFS But Not OS in Advanced Gastric or GEJ Adenocarcinoma. OncLive, 6 February 2024.
5. China accepts HUTCHMED’s fruquintinib NDA for gastric cancer. Pharmaceutical Technology, Accessed 08 May 2024.
6. Analysis of new drug registration and review in China in 2021. NCBI, Accessed 8 May 2024.