Cancer Space Update: 2 Drugs Receive Regulatory Nod In EU

There was not much activity in the U.S. cancer space this week. However, we saw two drugs getting regulatory nod from the European Commission ("EC"). Zejula received approval as monotherapy for the maintenance treatment of recurrent ovarian cancer patients. It is set to give AstraZeneca (NYSE:AZN) /Merck’s (NYSE:MRK) Lynparza a run for its money in the PARP-inhibitor space in Europe. On the other hand, Novartis’ (NYSE:NVS) Tasigna received approval for label expansion in the first-line setting for paediatric patients with chronic myeloid leukemia.

Meanwhile, Johnson & Johnson (NYSE:JNJ) submitted regulatory applications for label expansion of Darzalex as first-line therapy for multiple myeloma in both the United States and Europe. Moreover, Roche Holding (OTC:RHHBY) announced encouraging results from a phase III study evaluating Tecentriq in combination with chemotherapy in stage IV non-squamous non-small cell lung cancer ("NSCLC").

Recap of the Week’s Most Important Stories

TESARO’s Zejula Approved in Europe: The European Commission has granted marketing authorization to Zejula as maintenance treatment for women with recurrent ovarian cancer. It is the first PARP inhibitor to receive approval in Europe, which does not require BRCA mutation or other biomarker testing. The drug is already marketed in the United States in the same indication.

Zejula will now compete with Lynparza that is already approved in Europe. However, Zejula has an edge as Lynparza requires BRCA-mutation status in Europe. Zejula has performed well in the United States since launch. Similar adoption of the drug in Europe will aid the company. (Read more: TESARO Ovarian Cancer Drug Zejula Gets Approval in EU)

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Novartis’ Tasigna Gets Label Expansion in Europe: The EC approved the label expansion of Tasigna to include paediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP). The label will also include Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib (Gleevec).

Tasigna is already approved for adults in similar indications along with accelerated phase of CML in second or later line setting. (Read more: Novartis Receives EC Nod for Tasigna Label Expansion)

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J&J Seeking Darzalex’s Label Expansion: J&J submitted regulatory applications in the United States and Europe seeking label expansion of Darzalex in first-line setting for treating multiple myeloma (“MM”). The drug, if approved, will be used in combination with J&J’s proteasome inhibitor MM drug, Velcade (bortezomib), melphalan and prednisone in treatment-naïve patients who cannot have autologous stem cell transplantation in bone marrow.

Darzalex contributes almost a sixth of total J&J’s oncology sales. A potential label expansion approval in both the geographies will further boost its prospect. (Read more: J&J Seeks Darzalex's Label Expansion in First-Line Setting)

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Roche’s Tecentriq Impresses in a Phase III Combination Study: Roche announced encouraging results from phase III IMpower150 study, evaluating Tecentriq in NSCLC patients. The study was evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel), with or without Avastin.

The combination of Tecentriq and Avastin along with chemotherapy achieved statistically significant and clinically meaningful reduction in the risk of disease worsening or death compared to Avastin plus chemotherapy in people with stage IV NSCLC. The study was conducted on patients who did not receive any prior therapy. (Read more: Roche Reports Positive Data From Tecentriq Combination Study)

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Apart from these, Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced the initiation of a phase II study on its pipeline candidate, CDX-3379, in combination with Eli Lilly’s (NYSE:LLY) Erbitux. The study will evaluate the candidate in patients with advanced head and neck squamous cell carcinoma.

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