Antineoplastic drugs

Melanoma Research Alliance Hails FDA’s First ‘Triplet’ Combination Approval for Melanoma

Monday, August 3, 2020 - 9:13pm

The newly approved triplet treatment is the first FDA-approved combination for metastatic melanoma that brings together immunotherapy with targeted therapies.

Key Points: 
  • The newly approved triplet treatment is the first FDA-approved combination for metastatic melanoma that brings together immunotherapy with targeted therapies.
  • In the study, the triplet combination of Tecentriq + Cotellic and Zelboraf was compared to placebo + Cotellic and Zelboraf among patients with advanced BRAF-mutant melanoma.
  • This approval demonstrates the innovative spirit within the melanoma research community, says Dr. Marc Hurlbert, MRA Chief Science Officer.
  • Due to the ongoing support of its founders, 100 percent of donations to MRA go directly to its melanoma research program.

PharmAbcine signs a research collaboration agreement with Wuxi Shuangliang Biotechnology (SLBio) to evaluate a combination therapy to treat NSCLC

Monday, August 3, 2020 - 2:00pm

Olinvacimab, the leading clinical candidate being developed by PharmAbcine, has shown impressive safety profile and efficacy in clinical studies.

Key Points: 
  • Olinvacimab, the leading clinical candidate being developed by PharmAbcine, has shown impressive safety profile and efficacy in clinical studies.
  • It is currently in a phase II clinical trial in Australia and USA in bevacizumab non responding rGBM patients.
  • In addition, two phase Ib combination trials of olinvacimab and pembrolizumab are ongoing in mTNBC and in rGBM patients.
  • Thisstudy will give us a tremendous opportunity to explore an optimal combination of angiogenesis regulator and 3rd generation EGFR inhibitor to treat NSCLC."

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.

ImmunoGen Reports Recent Progress and Second Quarter 2020 Financial Results

Friday, July 31, 2020 - 11:30am

ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2020.

Key Points: 
  • ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2020.
  • Revenues in the second quarter of 2020 included $14.1 million in non-cash royalty revenues, compared with $10.4 million for the second quarter of 2019.
  • Operating expenses for the second quarter of 2020 were $33.4 million, compared with $56.6 million for the same quarter in 2019.
  • R&D expenses were $22.9 million in the second quarter of 2020, compared with $28.6 million for the second quarter of 2019.

Tarveda Therapeutics to Present at Upcoming Conferences

Thursday, July 30, 2020 - 1:00pm

Mr. Fromkin will also participate in a fireside chat at the BTIG Virtual Biotechnology Conference, occurring August 10-11, 2020.

Key Points: 
  • Mr. Fromkin will also participate in a fireside chat at the BTIG Virtual Biotechnology Conference, occurring August 10-11, 2020.
  • Tarvedas Pentarin miniature drug conjugates are designed to deeply penetrate solid tumors, selectively bind to the desired tumor targets and accumulate their anti-cancer payloads directly in tumor cells.
  • Tarveda currently has two Pentarin miniature drug conjugates in clinical trials.
  • Its first clinical program, PEN-866, is the initial candidate from its Heat Shock Protein 90 (HSP90) binding miniature drug conjugate platform.

Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC)

Thursday, July 30, 2020 - 11:45am

There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease.

Key Points: 
  • There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease.
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
  • At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment.

Peripheral T-Cell Lymphoma (PTCL) Market and Epidemiology Forecast, 2030 - ResearchAndMarkets.com

Thursday, July 30, 2020 - 10:35am

The "Peripheral T-Cell Lymphoma (PTCL) - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Peripheral T-Cell Lymphoma (PTCL) - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The PTCL market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM PTCL market size from 2017 to 2030.
  • The drug candidate is in Phase II stage of development for Peripheral T-cell lymphoma (PTCL) in Japan.
  • Adcetris and Istodax (Romidepsin) for the first line treatment of PTCL is projected to lead the market with the highest market share in 2030.

ImmunoGen Announces Webcast of Presentation at Upcoming Canaccord Genuity Virtual Growth Conference

Wednesday, July 29, 2020 - 9:30pm

ImmunoGen, Inc. , (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming 40th Annual Canaccord Genuity Virtual Growth Conference.

Key Points: 
  • ImmunoGen, Inc. , (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming 40th Annual Canaccord Genuity Virtual Growth Conference.
  • The presentation is scheduled for August 12, 2020 at 9:00am ET.
  • A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on www.immunogen.com .
  • ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients.

Celsion Corporation Initiates Phase II OVATION 2 Study of GEN-1 in Advanced Ovarian Cancer

Monday, July 27, 2020 - 1:30pm

LAWRENCEVILLE, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), an oncology focused drug-development company, today announced the randomization of the first two patients in the Phase II portion of the Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer.

Key Points: 
  • LAWRENCEVILLE, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), an oncology focused drug-development company, today announced the randomization of the first two patients in the Phase II portion of the Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer.
  • The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.
  • NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy.
  • and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.