Label updates could lead to sig­nif­i­cantly im­proved out­comes for patients with multiple myeloma

{{image}}Beerse, Belgium (Press Release) - Janssen-Cilag Inter­na­tional NV (Janssen) announced today that The Committee for Medical Products for Human Use (CHMP) of The European Medicines Agency (EMA) has granted a positive opinion on two variations relating to the use of VELCADE®.[1] VELCADE® is indicated for the treat­ment of multiple myeloma, a type of blood cancer.

The first recom­men­da­tion is for the use of VELCADE® (bor­tez­o­mib) as retreatment in adult patients who have pre­vi­ously responded to treat­ment with the same medicine.¹ The positive opinion re-enforces the ex­ist­ing data sup­porting the use of VELCADE® in this wider re­lapsed patient pop­u­la­tion in the European Union. This is now in­cluded in the label and does not require an addi­tional de­ci­sion from the European Commis­sion.

Concurrently, the CHMP also announced a positive opinion recommending the approval of VELCADE® as induction ther­apy in com­bi­na­tion with dexa­meth­a­sone (VD) or dexa­meth­a­sone and thalido­mide (VDT). This is for adult patients with pre­vi­ously untreated multiple myeloma who are eli­gible for high-dose che­mo­therapy with haematological stem cell trans­plan­ta­tion.¹ This will now be referred for approval to the European Com­mission.

VELCADE® was pre­vi­ously indicated for use in com­bi­na­tion with mel­phalan and pred­ni­sone for the treat­ment of multiple myeloma in adult patients that are pre­vi­ously untreated but in­eli­gible for high-dose che­mo­therapy with haematological stem cell trans­plant, and alone in ad­vanced multiple myeloma. These label updates could mean sig­nif­i­cantly im­proved out­comes for many patients with this disease.

VELCADE® (bor­tez­o­mib) as retreatment ther­apy [2]
The sub­mission for use of VELCADE® in adult patients who have pre­vi­ously been treated with the medicine but have since re­lapsed is sup­ported by data from the Phase II RETRIEVE (MMY2036) study. The pri­mary objective of this study was best con­firmed response at retreatment. This study in­cluded heavily pre-treated VELCADE® patients, who had pre­vi­ously achieved a partial or greater response, and had at least six months since their pre­vi­ous VELCADE® dose.

VELCADE® as induction ther­apy prior to stem cell trans­plan­ta­tion [3,4]
The sub­mission for license extension was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM) which dem­onstrated that treat­ment with VELCADE®-based induction resulted in im­prove­ments in pro­gres­sion-free survival (PFS), and post-induction and post-transplant response rates.

The trials studied the use of VELCADE®-based regi­mens VD and VDT, compared to non-VELCADE®-based regi­mens of vincristine plus doxorubicin and dexa­meth­a­sone, and thalido­mide and dexa­meth­a­sone, re­spec­tively, as induction ther­apy prior to au­tol­o­gous stem cell trans­plant in adult patients with pre­vi­ously-untreated multiple myeloma.

The CHMP
The CHMP is the committee responsible for the scientific assess­ment of prod­ucts seeking centralised mar­keting authori­sa­tion throughout the European Union.

The positive opinion on retreatment re-enforces the ex­ist­ing data sup­porting the use of VELCADE® in the re­lapsed patient pop­u­la­tion who have pre­vi­ously responded to treat­ment with the same medicine. The posi­tive opinion recommending VELCADE® as frontline induction ther­apy is now referred for approval to the European Com­mis­sion (EC) who will decide on whether to follow its guidance and grant an extension to the current European license for VELCADE®. Janssen ex­pec­ts that a de­ci­sion from the European Com­mis­sion on this will be announced in September 2013.

About VELCADE® [5,6] 
VELCADE® is a medicine used to treat the blood-based cancer known as multiple myeloma. It con­tains an active substance called bor­tez­o­mib and is the first in a new class of medicines known as pro­te­a­some in­hib­i­tors. Proteasomes are present in all cells and play an im­por­tant role in controlling cell function, growth and also how cells inter­act with the other cells around them. Bortezomib reversibly interrupts the normal work­ing of cell pro­te­a­somes causing myeloma cancer cells to stop growing and die.

Until now, it has been licensed in the EU for use in com­bi­na­tion with mel­phalan and pred­ni­sone in pre­vious­ly untreated adult patients with multiple myeloma (i.e. the front line setting) who are in­eli­gible for high-dose chemo­ther­apy with haematological stem cell trans­plant, and as mono­therapy for the treat­ment of pro­gres­sive multiple myeloma in patients who have received at least one prior ther­apy and who have already under­gone or are unsuitable for haematological stem cell trans­plant.

The European Com­mis­sion recently granted market­ing authori­sa­tion for the sub­cu­tane­ous (under the skin) admin­istra­tion of VELCADE® (bor­tez­o­mib) in the European Union. Subcutaneous bor­tez­o­mib has fewer side effects and offers greater convenience for patients, with similar efficacy compared to in­tra­venous bor­tezomib.

VELCADE® has a predictable safety profile and a favourable benefit–risk ratio. The most common side ef­fects reported with VELCADE®include fatigue, gastro­in­tes­ti­nal adverse events, transient thrombo­cytopenia and neu­rop­athy.

VELCADE® is the market leader in the treat­ment of front line non-transplant eli­gible multiple myeloma with over 400,000 patients treated world­wide. VELCADE® is co-developed by Millennium Pharma­ceu­ticals and Janssen Pharma­ceu­tical Com­panies. Millennium is responsible for com­mer­cial­iza­tion of VELCADE® in the U.S., Janssen Pharma­ceu­tical Com­panies are responsible for com­mer­cial­iza­tion in Europe and the rest of the world. Takeda Pharma­ceu­tical Company Limited and Janssen Pharma­ceu­tical K.K. co-promote VELCADE in Japan.

About multiple myeloma (MM)
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is char­ac­ter­ised by an excess proliferation of ab­nor­mal plasma cells. [7]

MM is the second most frequent form of malignant bone marrow diseases. It is a relatively rare form of can­cer that accounts for roughly one per­cent of all cancers and roughly two per­cent of all deaths from cancer. In Europe, around 60,000 people are living with the disease and there are 21,420 new cases and 15,000 deaths every year. [8]

About Janssen 
Janssen-Cilag Inter­na­tional NV (Janssen) is one of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson. We are dedicated to addressing and solving the most im­por­tant unmet medical needs of our time, in­­clud­ing on­col­ogy (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuro­science (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tu­ber­cu­lo­sis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated health­care solu­tions by work­ing side-by-side with health­care stakeholders, based on part­ner­ships of trust and transparency. More in­for­ma­tion can be found at www.janssen-emea.com

This press release con­tains "forward-looking state­ments" as defined in the Private Securities Litigation Re­form Act of 1995.  The reader is cautioned not to rely on these forward-looking state­ments. These state­ments are based on current ex­pec­ta­tions of future events.  If under­lying assump­tions prove inaccurate or unknown risks or un­cer­tain­ties ma­teri­alize, actual results could vary ma­teri­ally from the ex­pec­ta­tions and projections of Janssen Cilag Inter­na­tional NV, any of the Janssen Pharma­ceu­tical Com­panies and/or Johnson & Johnson.  Risks and un­cer­tain­ties in­clude, but are not limited to, general industry con­di­tions and com­pe­ti­tion; economic factors, such as interest rate and currency exchange rate fluctuations; technological ad­vances, new prod­ucts and patents attained by com­pet­i­tors; chal­lenges in­her­ent in new prod­uct devel­op­ment, in­­clud­ing obtaining regu­la­tory approvals; chal­lenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care prod­ucts and services; changes to gov­ern­mental laws and reg­u­la­tions and domestic and foreign health care reforms; trends to­ward health care cost con­tain­ment; and in­­creased scrutiny of the health care industry by gov­ern­ment agencies.  A further list and de­scrip­tion of these risks, un­cer­tain­ties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012.  Copies of this Form 10-K, as well as sub­se­quent filings, are avail­able online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  None of the Janssen Pharma­ceu­tical Com­panies nor Johnson & Johnson under­take to update any forward-looking state­ments as a result of new in­­for­ma­tion or future events or devel­op­ments.

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