• Dr. Reddy’s li­censed to sell vol­ume-limited amounts of ge­ner­ic lena­lido­mide in the U.S. be­gin­ning on a con­fi­den­tial date after the March 2022 date pre­vi­ously granted to Natco
• Dr. Reddy’s also li­censed to sell ge­ner­ic lena­lido­mide in the U.S. without vol­ume lim­i­ta­tion be­gin­ning on Jan­u­ary 31, 2026
• The earliest li­censed entry of any ge­ner­ic lena­lido­mide in the U.S. con­tinues to be March 2022, based on set­tle­ments reached

New York, NY (Press Release) – Bristol Myers Squibb (NYSE:BMY) to­day an­nounced that its wholly owned sub­sid­i­ary, Celgene, and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) have set­tled their lit­i­ga­tion re­lated 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 DRL from mar­ket­ing ge­ner­ic lena­lido­mide be­fore the expiration of the pat­ents-in-suit, except as provided for in the set­tle­ment, …

As you may remember from my pre­vi­ous column, I started treat­ment with Darzalex, Revlimid, and dexa­meth­a­sone in early Octo­ber.

By now, I have re­ceived six weekly Darzalex (dara­tu­mu­mab) in­fusions, and quite a bit has hap­pened as I adjust to being on a new regi­men.

After the first in­fusion, I had a mild cough that turned into quite a deep, hacking cough. I could hardly sleep for a week. It didn’t appear to be a "productive" cough, so I took Benadryl (di­phen­hy­dra­mine) and cough med­i­cines and sat upright a lot at …

Schweizer Forscher haben Ergebnisse einer kleinen klinischen Studie ver­öffentlicht, in der getestet wurde, ob Nelfinavir, ein ursprünglich zur Behand­lung von AIDS eingesetztes Medikament, die Resistenz gegen Revlimid bei rezidivierten Patienten mit multiplem Myelom überwinden kann.

Die Studie wurde durch frühere Untersuchungen motiviert, die zeigen, dass Nelfinavir bei vielen rezidivierten Myelompatienten die Resistenz gegen Velcade für einen gewissen Zeitraum überwinden kann.

Leider sind die Ergebnisse der neueren Nelfinavir-Studie nicht so ermutigend wie die bisherigen Unter­suchungen mit Nelfinavir und Velcade. Weniger als ein Drittel der Patienten in der neueren Studie sprach auf die Kombinationsbehandlung …

Swiss researchers have published results of a small clin­i­cal trial testing whether nelfinavir, a drug originally used to treat AIDS, can overcome resistance to Revlimid in re­lapsed multiple myeloma patients.

The trial was motivated by pre­vi­ous research showing that nelfinavir can overcome resistance to Velcade, for a period of time, in many re­lapsed myeloma patients.

Unfortunately, the results of the more recent nelfinavir trial are not as en­cour­ag­ing as the pre­vi­ous research involving nelfinavir and Velcade. Less than a third of the patients in the more recent trial responded to the three-drug …

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …

The European Com­mis­sion has approved two of Celgene’s IMiD®-based com­bi­na­tion regi­mens:

• REVLIMID in combi­nation with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
• IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), in adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing REVLIMID.

Boudry, Switzerland (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Com­mis­sion (EC) has approved two new triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD treat­ments, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd), is now indicated for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant. In addi­tion, IMNOVID, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), is now indicated for the treat­ment of adult patients with multiple myeloma who have received at …

The CHMP adopted two pos­i­tive opinions recommending European Com­mis­sion approval of:

• REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
• IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), for adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing lena­lido­mide

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted pos­i­tive opinions for two triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD® medications, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

The CHMP recommended approval of an expanded indi­ca­tion of REVLIMID as com­bi­na­tion ther­apy with bor­tez­o­mib and dexa­meth­a­sone (RVd) for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant.

The committee also recommended approval …