Articles tagged with: Lenalidomide

Opinion»

[ by | Feb 6, 2016 2:26 pm | 20 Comments ]
Myeloma Lessons: Decisions, Decisions

From the minute a person is diag­nosed with multiple myeloma, he or she is faced with a never-ending series of decisions. Because there are so many ways to approach treat­ment of the disease, and no consensus among experts on what approach to use, at the end of the day we must make these decisions for our­selves.

As myeloma research advances with the develop­ment of new drugs, new treat­ment combi­na­tions, and new studies on the efficacy of trans­planta­tion, these decisions become even more diffi­cult. After all, when the choices are limited, it’s easier …

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News, Opinion»

[ by | Jan 31, 2016 7:33 pm | 2 Comments ]
The Myeloma Quiz – January 2016

What a year 2015 was for the myelomatologist!

The U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of three new myeloma drugs, all within the span of a few weeks to­wards the end of the year, had already gen­er­ated great ex­cite­ment in the com­munity.

Then, sev­er­al poten­tial prac­tice-changing pre­sen­ta­tions at the 2015 American Society of He­ma­tol­ogy (ASH) annual meeting put the proverbial icing on the cake to round out a landmark year for myeloma thera­peutics.

This edition of the myeloma quiz highlights some of the key takeaways from the ASH 2015 meeting.

 …

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Press Releases»

[ by | Dec 22, 2015 4:31 pm | Comments Off ]
  • Natco to Acquire License to Sell Generic Lena­lido­mide in the U.S. Without Volume Limitation commencing in late Jan­u­ary­, 2026
  • License Will Also Provide Natco With a Volume-Limited Entry Beginning in March, 2022 with Anticipated Mid-Single-Digit Percentage Of Capsules Sold In the First 12 Months, Anticipated to Increase Gradually Each Year

Celgene Settles Revlimid Patent Litigation Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced the settle­ment of lit­i­ga­tion with Natco Pharma Ltd. of India, Natco’s U.S. partner, Arrow Inter­na­tional Limited, and Arrow’s parent com­pany, Watson Laboratories, Inc. (a wholly-owned sub­sid­i­ary of Allergan plc) relating to patents for REVLIMID® (lena­lido­mide).

As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Natco from mar­ket­ing generic lena­lido­mide before the expiration of the patents-in-suit, …

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Press Releases»

[ by | Dec 21, 2015 1:00 am | Comments Off ]
Oral Revlimid Plus Dexamethasone Granted Approval For Treatment Of Patients With Newly Diagnosed Multiple Myeloma In Japan

Boudry, Switzerland, and Tokyo (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that REVLIMID® (lena­lido­mide), a cancer medi­cine that is admin­istered orally, has been granted full market­ing authori­za­tion by Japan’s Ministry of Health, Labour and Welfare (MHLW) for use in com­bi­na­tion with dexa­meth­a­sone as a treat­ment for patients newly diag­nosed with multiple myeloma. This market­ing authori­za­tion expands upon the approval of REVLIMID in 2010 for the treat­ment of patients with re­lapsed or refractory multiple myeloma.

“The approval of REVLIMID as an option for use in …

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Press Releases»

[ by | Dec 7, 2015 7:00 am | Comments Off ]

Findings Presented at the 57th American Society of Hematology Annual Meeting Demonstrate Activity of KEYTRUDA Therapy in Previously-Treated Multiple Myeloma Patients When Combined with Lena­lido­mide and Dexamethasone

Responses Observed In Three-Quarters Of Heavily Pre-Treated Multiple Myeloma Patients Receiving Keytruda (Pembrolizumab) Combined With Lenalidomide And Dexamethasone Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today new study findings investigating the use of KEYTRUDA® (pem­bro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone (two com­monly used treat­ments for multiple myeloma) in patients whose dis­ease has progressed after at least two lines of prior ther­apy, in­clud­ing a pro­te­a­some inhibitor and an IMiD (immune modulatory drug). The initial findings from the ongoing Phase 1 KEYNOTE-023 study showed an over­all response rate (ORR) of 76 per­cent (n=13/17), as assessed by …

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Press Releases»

[ by | Dec 6, 2015 11:05 am | Comments Off ]

Results featured at the 57th Annual American Society of Hematology Meeting and Exposition:

  • 72 per­cent of re­lapsed or refractory multiple myeloma patients treated with dara­tu­mu­mab com­bi­na­tion ther­apy did not progress or relapse after 18 months of treat­ment (GEN 503)
  • Daratumumab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone produced rapid, deep and durable responses in re­lapsed and refractory multiple myeloma patients who had received at least two (median of 3.5) prior lines of ther­apy, in­­clud­ing two or more consecutive cycles of lena­lido­mide and bor­tez­o­mib, and were refractory to their last line of treat­ment (MMY1001 Phase1b)
  • Single-agent dara­tu­mu­mab dem­onstrated a median over­all survival of 20 months in heavily pre-treated re­lapsed and refractory multiple myeloma patients who have exhausted other approved treat­ment options. A partial response or better was achieved by 31 per­cent of patients, and 83 per­cent achieved stable disease or better (GEN 501 & MMY2002)

Daratumumab Combined With Standard Treatment For Multiple Myeloma Produced Deep And Durable Responses In Relapsed Or Refractory Patients Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced new data from the ongoing Phase 1/2 GEN503 inves­ti­ga­tional study showing the human CD38-directed mono­clonal anti­body dara­tumumab, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, yielded an over­all response rate (ORR) of 81 per­cent in re­lapsed or refractory multiple myeloma patients who had received a median of two prior ther­a­pies. After 18 months of treat­ment, investigators observed an over­all survival (OS) rate of 90 per­cent, with 72 per­cent …

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News»

[ by | Jun 1, 2015 7:55 pm | 7 Comments ]
ASCO 2015 Multiple Myeloma Update – Poster Presentations: Current Therapies; Impact Of Del(17p) And T(11;14)

A poster session yesterday at the 2015 American Society of Clinical Oncology (ASCO) annual meeting was the venue for the first substantial dose of multiple myeloma-related presentations at the conference.

During the session, research results were made available for review by meeting attendees in the form of posters, each of which summarized the results of a single study. As is typically the case during such sessions, each poster was about two feet high by three or four feet in length. All posters were displayed throughout a large conference hall.

Most of the …

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