Roche AG RHHBY announced that the European Commission (EC) has approved Phesgo, a fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection, for the treatment of early and metastatic HER2-positive breast cancer.
Shares of the company have risen 7.2% so far this year compared with the industry’s growth of 5.3%.
The approval is supported by the phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood and demonstrated comparable efficacy versus IV administration of the two medicines.
Treatment with Phesgo is more than 90% faster, administered under the skin in just minutes compared to hours with intravenous (IV) infusion of Perjeta plus Herceptin. Subcutaneous administration is preferred by patients, physicians and healthcare providers, and is associated with a reduction in healthcare costs.
We note that Phesgo was approved by the FDA in June 2020 for the treatment of early and metastatic HER2-positive breast cancer. It is administered as a subcutaneous (“SC”) injection in combination with intravenous (“IV”) chemotherapy.
Please note that Perjeta in combination with Herceptin and chemotherapy (the Perjeta-based regimen) is also approved by the FDA as an adjuvant (after surgery) treatment of HER2-positive early breast cancer patients, who are at a high risk of recurrence. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.
We would like to remind investors that Roche has a strong presence in the oncology market. Particularly, it dominates the breast cancer space with solid demand for its HER2 franchise drugs, namely Herceptin, Perjeta and Kadcyla.
However, competition looms large in the HER2-positive breast cancer space. Puma Biotech’s PBYI Nerlynx (neratinib) is also approved for use as an extended adjuvant treatment of HER2-positive early-stage breast cancer in adult patients, who were previously treated with Roche’s Herceptin-based adjuvant therapy.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. ARPO and ASLAN Pharmaceuticals Ltd. ASLN, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days. Share price of the company has increased 65.2% year to date.
ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days.
Roche Holding AG Price
Roche Holding AG price | Roche Holding AG Quote
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