Roche Holding AG’s RHHBY member, Genentech announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of subcutaneous Rituxan /hyaluronidase for the treatment of patients with certain blood cancers. The indications include previously untreated follicular lymphoma and diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL). The FDA is expected to make a decision on approval by June 26, 2017.

The new co-formulation contains the same monoclonal antibody as intravenous Rituxan and hyaluronidase, a molecule that helps to deliver medicine under the skin.

Roche’s share price shows that the company has outperformed the Zacks classified Large Cap Pharmaceuticals industry year to date. The stock improved 12.6% compared with the industry’s Large Cap Pharmaceuticals gain of 6.6%.

We note that Rituxan injection for intravenous use is indicated in the U.S.  for the treatment of patients with previously untreated follicular lymphoma and DLBCL, relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory CLL.

In fact, subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan.  The ease in administration should further boost sales on approval.

The ODAC recommendation was based on a review of data from five clinical trials that included 2,000 patients with the various blood cancers for which Rituxan IV currently received an approval. The studies showed that subcutaneous administration of the co-formulation resulted in non-inferior levels of rituximab in the blood (pharmacokinetics) and consistent clinical efficacy and safety outcomes compared to intravenous Rituxan.

Recently, Roche announced that the FDA has granted Breakthrough Therapy Designation status to Rituxan for the treatment of pemphigus vulgaris.

In addition to approved medicines, Genentech’s pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388).

Roche Holding AG Price

Roche Holding AG Price | Roche Holding AG Quote

Zacks Rank & Stocks to Consider

Roche currently carries a Zacks Rank #2 (Hold). O Other favorable stocks in the health care sector include Heska Corp. HSKA, Retrophin, Inc. RTRX and Galena Biopharma, Inc. GALE. All the three companies carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

Heska’s earnings estimates moved up from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the last four quarters, with an average beat of 291.54%. Its share price increased 33.8% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.  

Galena Biopharma‘s loss estimates narrowed from $2.53 to 58 cents for 2017 and from $1.95 to 73 cents for 2018, over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 53.83%.  

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