The Pharma Data

SEPTEMBER 19, 2020

months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). The OS data showed a negative trend; however, the study was not powered for the secondary endpoint of OS, and OS data were immature at time of analysis (initial HR=1.55 [95% CI: 0.86-2.80]

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Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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HR Hormones FDA Approval Antibody 264

Pharmaceutical Technology

AUGUST 8, 2022

According to the trial data, Enhertu lowered disease progression or mortality risk by 50% compared with chemotherapy according to the physician’s choice in HER2-low metastatic breast cancer patients with hormone receptor (HR)-positive disease or HR-negative disease. months compared with 5.1 months for the chemotherapy arm.

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FDA Approval HR Clinical Trials Clinical Trials 264

pharmaphorum

DECEMBER 12, 2022

Along with data from its antibody-drug conjugates and oral selective oestrogen receptor degrader (SERD) camizestrant reported earlier, AZ presented results of the CAPItello trial of AKT inhibitor capivasertib in combination with injectable SERD Faslodex (fulvestrant) in hormone receptor positive, HER2-negative advanced breast cancer.

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The Pharma Data

MARCH 7, 2022

Nasdaq: GILD) today announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Gilead Sciences, Inc.

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XTalks

FEBRUARY 7, 2023

HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2

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HR Hormones FDA Approval Antibody 52

XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review. billion to $1.28

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XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

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FDA Approval Drugs Sales Development 101

The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on blinded independent central review (BICR).

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pharmaphorum

JUNE 6, 2022

The trial evaluated Trodelvy (sacituzumab govitecan) in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment, and showed that the drug extended progression-free survival to 5.5 At ASCO the numbers have been revealed, and the picture isn’t much clearer.

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HR Hormones Trials Drugs 52

The Pharma Data

APRIL 27, 2022

1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.

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The Pharma Data

SEPTEMBER 16, 2020

Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation. HR-positive breast cancer. GDC-0077 is our next generation investigational PI3K? Ipatasertib.

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HR Medicine Hormones Trials 52

pharmaphorum

AUGUST 8, 2022

It has the potential to be a sizeable new indication for Enhertu (trastuzumab deruxtecan), a HER2-targeting antibody-drug conjugate, and central to AZ and Daiichi Sankyo’s hopes of unlocking multibillion-dollar sales for the drug.

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HR Hormones Sales Antibody 52

XTalks

MARCH 22, 2021

The biotech acquisition deal includes Five Prime’s prime asset bemarituzumab, which is a first-in-class anti-FGFR2b antibody. The antibody accrued promising data in a randomized, placebo-controlled Phase II study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer, and is now being prepared for Phase III trials.

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XTalks

FEBRUARY 5, 2024

Why it did so well: Darzalex was the first human anti-CD38 monoclonal antibody approved by the FDA for multiple myeloma. It is prescribed for the treatment of metastatic breast cancer in patients with HR-positive/HER2-negative status. Darzalex (Daratumumab) Darzalex 2022 Sales: $7.977 billion Company/Developer: Janssen Biotech, Inc.,

FDA Approval 52

FDA Approval Drugs Sales Development 52

The Pharma Data

APRIL 7, 2021

months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months (HR: 0.51; 95% CI: 0.41-0.62; months from 1.7 0.54; p<0.0001). Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 0.62; p<0.0001), representing a 49% reduction in the risk of death. About Trodelvy.

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HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

APRIL 14, 2021

Trodelvy is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer. More information on TROPiCS-04 is available at [link]. About Trodelvy.

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Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

1 With up to seven years of follow-up, progression-free survival (PFS) benefit with single-agent IMBRUVICA was sustained (Hazard Ratio [HR] 0.160 [95 percent Confidence Interval (CI): 0.111–0.230]). The BTK protein sends important signals that tell B cells to mature and produce antibodies. Isolated growth hormone deficiency. ?

FDA Approval 40

FDA Approval Medicine Development Trials 40

XTalks

AUGUST 10, 2022

Enhertu is an antibody-drug conjugate (ADC) consisting of Roche’s Herceptin (trastuzumab), a monoclonal antibody against HER2 (human epidermal growth factor receptor 2), and the topoisomerase I inhibitor deruxtecan. The trial included 494 hormone receptor positive (HR+) patients and 63 hormone receptor negative (HR-) patients.

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FDA Approval HR Hormones Antibody 98

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells.

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The Pharma Data

JANUARY 4, 2021

months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Co-primary endpoints are overall response rate and progression-free survival.

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Medicine Immune Response Protein Gene 52

Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. No dosage adjustment is needed in patients with mild renal impairment.

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XTalks

NOVEMBER 26, 2024

Xtandi is also prescribed for metastatic prostate cancer that continues to respond to hormone therapy. This latest approval makes Xtandi the first androgen receptor signaling inhibitor approved for use without gonadotropin-releasing hormone therapy in non-metastatic castration-sensitive prostate cancer. billion in global sales in 2023.

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The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. Isolated growth hormone deficiency. ?

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Medicine Production FDA Approval Development 52

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; A decision from the EC is expected in 2022.

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Vaccine Vaccination Production Sales 40