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Boston Scientific's (BSX) TheraSphere Approved by FDA for HCC

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Boston Scientific Corporation (BSX - Free Report) recently announced receipt of the FDA’s approval for its TheraSphere Y-90 Glass Microspheres, which have been developed for the treatment of hepatocellular carcinoma (“HCC”) patients. Notably, the approval for TheraSphere was based on results from the LEGACY study, designed to assess the safety and efficacy of the therapy for the treatment of early and advanced HCC.

For investors’ note, the TheraSphere therapy is now applicable for use on more patients following the approval, which was till date being utilized under a humanitarian device exemption (“HDE”). TheraSphere has now become the only radioembolization technology (type of radiation therapy used to treat liver cancer or cancer that has spread to the liver) indicated for the treatment of unresectable HCC in the United States.

It should be noted that HDE is an FDA classification which requires institutional review board’s approval and restricts the number of patients treated with the therapy every year.

With the latest FDA clearance, Boston Scientific’s interventional oncology product line of the Peripheral Interventions business is expected to receive a significant boost on a global scale. Notably, Peripheral Interventions is a part of the broader Cardiovascular arm.

Few Words on TheraSphere Therapy

In the TheraSphere treatment, a type of selective internal radiation therapy (“SIRT”) with low toxicity, millions of microscopic glass beads containing radioactive yttrium (Y-90) are delivered directly to liver tumors via catheter. This results in minimal exposure to surrounding healthy tissues. TheraSphere treatment does not require hospitalization and is usually performed as an outpatient procedure within an hour.

Significance of the Approval

Per estimates, HCC is one of the most prevalent cancers worldwide, and the most common type of primary liver cancer, with more than half a million new global cases diagnosed annually. The American Cancer Society anticipates registering approximately 32,000 new cases of HCC in the United States alone, in 2021, which are generally treated through various processes like embolization, including both chemoembolization and radioembolization (also known as SIRT).

Per a medical expert associated with the LEGACY trial, TheraSphere has been established as a standard treatment for the HCC patient population on the back of positive response during treatment.

The National Institute for Health and Care Excellence (“NICE”) has recently issued a guidance recognizing the benefits of SIRT to both patients and hospitals, and has recommended the use of TheraSphere for the treatment of patients with HCC through the National Health Service.

Per management, the recent FDA nod and NICE recommendation is expected to expand access to TheraSphere to more patients globally.

Industry Prospects

Per a report by Market Data Forecast, the global liver cancer therapeutics market is expected to reach $1052.37 million by 2025 from $680.84 million in 2020, at a CAGR of 9.1%. Factors like the increasing prevalence of liver cancer and the increasing research and development investments for the development of novel therapies are expected to drive the market.

Given the market potential, the latest FDA clearance is expected to strengthen Boston Scientific’s foothold across the globe.

Recent Developments in Cardiovascular Arm

Of late, Boston Scientific has been witnessing few developments across its business.

The company, during its fourth-quarter earnings call in February this year, registered robust organic sales growth, which reflects an overall mix of high acuity as well as a strong portfolio and a broad cadence of new product launches.

Boston Scientific received the FDA’s approval for its Ranger Drug-Coated Balloon in November 2020. The balloon was developed for the treatment of patients with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.

Price Performance

Shares of the company have gained 47.8% in the past year compared with the industry’s 60.9% rise and the S&P 500’s 76.6% growth.

Zacks Rank & Stocks to Consider

Currently, Boston Scientific carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Hologic, Inc. (HOLX - Free Report) , IDEXX Laboratories, Inc. (IDXX - Free Report) and Abbott Laboratories (ABT - Free Report) .

Hologic’s long-term earnings growth rate is estimated at 15.4%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

IDEXX’s long-term earnings growth rate is estimated at 15.8%. It currently carries a Zacks Rank #2.

Abbott’s long-term earnings growth rate is estimated at 14.1%. The company presently carries a Zacks Rank #2.

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