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Roche’s SC Formulation of Perjeta-Herceptin Combo Gets FDA Nod

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Roche RHHBY announced that the FDA has approved a fixed-dose combination (“FDC”) of its breast cancer drugs — Perjeta (pertuzumab) and Herceptin (trastuzumab) — as treatment for early and metastatic HER2-positive breast cancer. The drug is available under the tradename of Phesgo and will be administered as subcutaneous (“SC”) injection in combination with intravenous (“IV”) chemotherapy.

Please note that Perjeta in combination with Herceptin and chemotherapy (the Perjeta-based regimen) is already 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. The drugs are administered using separate IV injection.

For the first time, Roche has combined two monoclonal antibodies that can be administered by a single SC injection. Phesgo is marketed one single-dose vial and will reduce administration time significantly. Currently, a sequential IV infusions of a loading dose of Perjeta and Herceptin in breast cancer patient takes approximately 150 minutes. Subsequent maintenance infusions of the two drugs takes between 60-150 minutes. While the new SC, fixed-dose, single-vial formulation of Perjeta and Herceptin combination will take approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. Phesgo can also be administered in a treatment center or at a patient’s home.

An easy-to-use SC injection and lower administration time for Phesgo will likely increase the drug’s adoption among healthcare professionals as well as patients, leading to sales growth. Data from a phase II study — PHranceSCa — showed that 85% of patients receiving treatment for HER2-positive breast cancer preferred treatment SC (under the skin) to IV administration due to less time in the clinic and more comfortable treatment administration.


Please note that the FDC of Perjeta and Herceptin is a new SC formulation, which uses Halozyme Therapeutics’ HALO ENHANZE drug delivery technology.

The approval for Phesgo was based on data from a phase III study — FeDeriCa — which demonstrated non-inferior levels of Perjeta in the blood compared to the standard IV infusion of Perjeta + Herceptin and chemotherapy in patients with HER2-positive early breast cancer.

Shares of Roche have risen 7.5% so far this year versus the industry’s decrease of 3.5%.

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 on 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 & Stock to Consider

Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock from the pharma/biotech sector is Vertex Pharmaceuticals Incorporated VRTX, which sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vertex’s earnings estimates have been revised 1% upward for 2020 and 1.4% for 2021 over the past 30 days. The stock has rallied 30.2% year to date.

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