Lenalidomide

DGAP-News: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 1:00am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • "The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte.
  • "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 12:51am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States, said Herv Hoppenot, Chief Executive Officer, Incyte.
  • The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Friday, July 31, 2020 - 8:38pm

We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone.

Key Points: 
  • We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone.
  • This Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI.
  • In the original design of the study, patients in the daratumumab plus Pd arm were treated with the IV formulation of daratumumab.
  • A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings.

New Phase II data indicate regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma

Monday, June 15, 2020 - 1:00am

3 patients experienced higher than grade 2 toxicity and the most common adverse event regardless of grade was skin toxicity, observed in 4 patients.

Key Points: 
  • 3 patients experienced higher than grade 2 toxicity and the most common adverse event regardless of grade was skin toxicity, observed in 4 patients.
  • By incorporating biosimilar rituximab into combination therapies alongside new drugs, the overall cost burden can be reduced, enhancing patient access.
  • DLBCL is an aggressive condition and it is common to find patients with advanced disease at the point of diagnosis.
  • Rituximab, lenalidomide and acalabrutinib (R2A) for relapsed/refractory aggressive B-cell lymphoma: Interim analysis reporting good tolerability and potential durable response.

European Commission Grants Marketing Authorisation for DARZALEX®▼(daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications

Thursday, June 4, 2020 - 3:00pm

The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.

Key Points: 
  • The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.
  • Patients with relapsed or refractory disease were treated with 1,800 mg of daratumumab SC plus lenalidomide and dexamethasone (D-Rd).
  • Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial.
  • A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma.

Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX® (daratumumab) for the Treatment of Patients with Multiple Myeloma

Thursday, June 4, 2020 - 2:42pm

We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab.

Key Points: 
  • We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab.
  • The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma.
  • Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd).
  • Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma.

DGAP-News: MorphoSys and Incyte Announce Long-term Follow-up Results from L-MIND Study of Tafasitamab in Patients with r/r DLBCL

Thursday, May 14, 2020 - 3:08pm

In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis.

Key Points: 
  • In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis.
  • "The updated data for L-MIND reinforce the potential of tafasitamab in combination with lenalidomide as treatment for patients with r/r DLBCL.
  • In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.
  • If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States while Incyte has exclusive commercialization rights outside the United States.

Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma

Tuesday, May 12, 2020 - 6:00am

This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.

Key Points: 
  • This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.
  • The randomized, multi-center, open label Phase 3 IKEMA clinical trial enrolled 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries.
  • Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with multiple myeloma.
  • Multiple myeloma is the second most common hematologic malignancy, with more than 138,000 new diagnoses of multiple myeloma worldwide yearly.

KYPROLIS® (carfilzomib) Patents Upheld Against Generic Manufacturer

Tuesday, May 5, 2020 - 2:00pm

Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.

Key Points: 
  • Withhold KYPROLIS for Grade 3 or 4 cardiac adverse events until recovery, and consider whether to restart at 1 dose level reduction based on a benefit/risk assessment.
  • Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy.
  • Withhold KYPROLIS for PAH until resolved or returned to baseline and consider whether to restart based on a benefit/risk assessment.
  • Thromboprophylaxis is recommended for patients being treated with the combination of KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone.

Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), for the Treatment of Patients with Multiple Myeloma

Friday, May 1, 2020 - 6:36pm

The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab.

Key Points: 
  • The approval of the subcutaneous formulation of daratumumab, DARZALEX FASPRO, is a landmark event in the development of daratumumab.
  • The Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma.
  • Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd).
  • DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.