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. billion to $1.28

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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pharmaphorum

JANUARY 26, 2023

In Europe, approximately 531,000 breast cancer patients are diagnosed annually, with around 141,000 deaths, and around half of all cases would fall under the HER2-low classification, split between patients with both hormone receptor (HR) positive and HR negative disease. months to 23.4

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pharmaphorum

OCTOBER 11, 2020

When added to standard treatment with hormone-based drugs, Ibrance (palbociclib) was unable to achieve better iDFS than hormone therapy alone in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early-stage breast cancer.

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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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Drug Discovery World

JUNE 1, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2. DDW’s Megan Thomas explores three trends in the market.

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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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Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Findings of the study, reported at the ESMO Congress 2022, demonstrated a 3.2-month

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The Pharma Data

APRIL 7, 2021

The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; months vs. 6.9

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The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). About Metastatic Castration-Sensitive Prostate Cancer.

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The Pharma Data

JULY 22, 2021

The approval for this population is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84];

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The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

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The Pharma Data

JANUARY 4, 2021

months with Tecentriq alone; HR=0.30, 95% CI: 0.15–0.61). If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. Their cancer tests positive for “PD-L1”.

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Pfizer

JANUARY 27, 2023

COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

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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]). IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. Isolated growth hormone deficiency. ? November 2020.

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The Pharma Data

FEBRUARY 8, 2021

months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001). 2 ERLEADA ® received U.S.

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Pharmaceutical Technology

MARCH 2, 2023

It is under development for the treatment of spindle cell squamous cell carcinoma, giant cell carcinoma, gastroenteropancreatic neuroendocrine tumor (GEP-NETs), extrahepatic bile duct cancer, colon tumor, rectal tumor, cervical cancer, vulvar cancer.

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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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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Somatrogon — In February 2021, Pfizer and OPKO Health Inc.

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