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JOHNSON & JOHNSON

(JNJ)
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Delayed Nyse  -  04:00 2022-09-28 pm EDT
166.36 USD   +0.86%
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The Janssen Pharmaceutical Companies - European Commission Approves IMBRUVICA (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

08/05/2022 | 07:56am EDT

BEERSE, BELGIUM - The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA (ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). The approval is based on the pivotal Phase 3 GLOW study that demonstrated superior progression-free survival (PFS) in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O), and the FD cohort of the Phase 2 CAPTIVATE study, which showed deep and durable responses in patients treated with I+V, including those with high-risk features.[1],[2]

'Developing innovative therapies remains vitally important in CLL, to ensure we have the option and ability to best tailor treatment to meet individual patient needs and preferences,' said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. 'Over the past 11 years, the efficacy and safety profile of ibrutinib has been established in clinical trials and real-world settings. With this approval, healthcare professionals will now have the flexibility to use ibrutinib either in a fixed-duration combination with venetoclax or as a continuous monotherapy in first-line CLL.'

In Europe, ibrutinib is already approved as a continuous therapy in several indications across three blood cancers (CLL, mantle cell lymphoma and Waldenstrom's macroglobulinaemia).[3] In CLL, patient outcomes have improved over the last decade.[4] A wave of innovation, including the advent of novel oral therapies that target the underlying disease biology, has shifted the standard of care from chemoimmunotherapy to targeted agents and combination therapies.4 Unmet needs remain, including time-limited combinations of targeted therapies that provide durable remissions and the flexibility to better tailor first-line therapy.1

'The distinct and complementary mechanisms of action of ibrutinib and venetoclax, and the potential of this combination regimen to provide treatment-free remissions, mark important progress for how we approach first-line CLL therapy,' said Arnon Kater(+), M.D., Ph.D., Deputy Head of Haematology, Amsterdam University Medical Centres, University of Amsterdam and Chairman of the HOVON CLL Working Group, the Netherlands and GLOW principal study investigator. 'These highly active blood cancer treatments not only combine to deliver superior progression-free survival versus chlorambucil plus obinutuzumab, but also demonstrate robust disease clearance in lymphoid tissue, blood and bone marrow, and early sustainability of those responses after stopping treatment.'

The EC approval is supported by data from the pivotal Phase 3 GLOW study (NCT03462719), which demonstrated that I+V was superior to Clb+O with respect to the primary endpoint, PFS assessed by an independent review committee, in elderly or unfit patients with CLL (PFS hazard ratio [HR]: 0.216; 95 percent confidence interval [CI], 0.131 to 0.357; P

(C) 2022 Electronic News Publishing, source ENP Newswire

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Financials (USD)
Sales 2022 95 525 M - -
Net income 2022 22 023 M - -
Net cash 2022 9 791 M - -
P/E ratio 2022 20,4x
Yield 2022 2,63%
Capitalization 437 B 437 B -
EV / Sales 2022 4,48x
EV / Sales 2023 4,19x
Nbr of Employees 141 700
Free-Float 84,2%
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Number of Analysts 20
Last Close Price 166,36 $
Average target price 185,07 $
Spread / Average Target 11,2%
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Managers and Directors
Joaquin Duato Chief Executive Officer & Director
Joseph J. Wolk Chief Financial Officer & Executive Vice President
Matthew Stuckley Senior Financial Analyst-Janssen Commercial Pharm
Alex Gorsky Executive Chairman
Peter Shen Global Head-Research & Development
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