Daiichi Sankyo Archives - Medical Design Sourcing

FDA approves Enhertu for HER2-low breast cancer

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer.

Enhertu is now the first approved therapy for patients with HER2-low breast cancer subtype.

The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for metastatic cancer or if their cancer returned within 6 months of completing an adjuvant chemotherapy regimen.

Patients with low levels of the HER2 protein have traditionally had fewer treatment options than patients with HER2-positive breast cancer, according to the National Cancer Institute. Treatment options for such patients typically included endocrine therapy or chemotherapy.

Overall, about 2 million women per year are diagnosed with breast cancer.

FDA estimated that approximately 60% of patients with…

Enhertu slashed risk of disease progression or death by half compared to chemotherapy HER2-low breast cancer

AstraZeneca (LON:AZN) and Daiichi Sankyo’s (OTCMKTS:DSNKY) Enhertu (fam-trastuzumab deruxtecan-nxki) showed a dramatic survival benefit in the pivotal DESTINY-Breast04 Phase 3 study focused on a subset of breast cancer patients. The DNA topoisomerase I inhibitor improved median overall survival by more than six months compared to chemotherapy in the study. In addition, the drug met the primary endpoint of progression-free survival in the study, cutting the risk of disease progression or death by 49% compared to chemotherapy.

AstraZeneca reports that the therapy could potentially redefine treatment for roughly half of breast cancer patients.

The DESTINY-Breast04 study focused on previously-treated patients with HER2-low unresectable or metastatic breast cancer.

AstraZeneca notes that Enhertu is the first HER2-focused therapy to show a survival benefit in the patient demographic.

Enhertu met the primary endpoint of progression-free survival in patie…

AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA.

Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY).

The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.

Of the five breakthrough therapy designations for the drug, three are for breast cancer, while the other two are in lung and gastric cancers, respectively.

In particular, the designation covers adults who have received prior systemic therapy for metastatic breast cancer or who have experienced disease recurrence within six months of finishing adjuvant chemotherapy.

In addition, the designation specifies that patients with hormone receptor (HR) positive breast cancer have received or be inelig…

FDA grants Enhertu priority review for HER2-positive positive metastatic breast cancer

FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY).

The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen.

FDA also granted priority review to the application.

In 2019, Enhertu first won FDA approval for HER2-positive unresectable or metastatic breast cancer after two or more prior anti-HER2-based regimens.

Two years later, the agency extended approval to patients with previously-treated HER2-positive advanced gastric cancer.

The recent application includes data from the DESTINY-Breast03 study,

That study found that Enhertu demonstrated a statistically significant improvement in progression-free survival compared with trastuzumab emtansine (T-DM1) (Kadcyla…

Daiichi Sankyo’s valemetostat fares well in lymphoma and leukemia study

Valemetostat, a potential first-in-class drug from Daiichi Sankyo, led to durable tumor response in patients with peripheral T-cell lymphoma (PTCL) and adult T-cell leukemia/lymphoma (ATL) in a Phase 1 study.

The company presented highlights from the trial at the European Hematology Association (EHA) 2021 Virtual Congress today.

In the study, the objective response rate was 54.5% in 44 patients with PTCL. That tally included 12 complete responses and 12 partial responses. The median duration of response was 56 weeks.

[Related: View the 50 largest pharmaceutical companies of 2020]

Valemetostat inhibits two enzymes known as enhancer of zeste homolog 1 and 2 (EZH1/EZH2).

Researchers have observed altered EZH2 expression in the development and progression of blood cancers such as non-Hodgkin lymphomas (NHLs) and adult T-cell leukemia/lymphoma (ATL). EZH1 also plays a role in hematologic cancer progression.

Daiichi Sankyo has noted …

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Get the full picture from our sister site, Drug Discovery & Development.

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]

The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)