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Roche (RHHBY) Alecensa Wins FDA Nod for Label Expansion

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Roche (RHHBY - Free Report) announced that the FDA has approved a label expansion of its lung cancer drug, Alecensa.

The drug is now approved for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node-positive), as detected by an FDA-approved test.

Alecensa is a kinase inhibitor, already approved as the first and second-line treatment for ALK-positive metastatic NSCLC, in various countries like the United States, Europe, Japan and China.

The latest approval has made Alecensa the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.

The approval was based on results from the phase III ALINA study, which showed Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected NSCLC.

The approval provides a treatment option for patients newly diagnosed with early-stage ALK-positive lung cancer, who until now were not able to receive ALK-specific therapy.

Per Roche, about half of patients with early-stage NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy. Hence, Alecensa can now address this patient population.

The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.

Data from the late-stage ALINA study will also be used for filing submissions to additional global health authorities, including the European Medicines Agency.

Alecensa generated sales of CHF 1.5 billion in 2023, up 8% year over year. Label expansion of the drug should boost sales.

Roche’s shares have lost 9.9% in the past six months against the industry’s growth of 11.9%.

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Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel Roche’s top line as the company looks to fill up the dent in sales caused by a decline in COVID-19-related sales. Competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin continues to hurt sales.

Approval of new drugs and label expansion of the existing ones should bode well for Roche in this scenario. Vabysmo has put up a stellar performance against Regeneron’s Eylea, whose sales are under pressure.

In February, the FDA approved a label expansion of the asthma drug Xolair (omalizumab). The regulatory body approved the drug for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged one year and older with IgE-mediated food allergy.

Earlier in the week, Roche announced that the late-stage study (STARGLO) evaluating its marketed drug, Columvi (glofitamab), in combination with gemcitabine and oxaliplatin (GemOx), for the treatment of relapsed or refractory diffuse large B-cell lymphoma met its primary endpoint of overall survival. 

Zacks Rank & Stocks to Consider

Roche currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. Shares of ADMA have rallied 37.2% year to date.

ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, delivering an average surprise of 85.00%.

In the past 60 days, estimates for Ligand’s 2024 EPS have improved from $4.42 to $4.56. Shares of LGND have risen 10.4% year to date.

LGND’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 84.81%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.12 to $4.43. Shares of ANIP have jumped 17.1% year to date.

ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.


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