FDA

FDA Approves Genentech’s Tecentriq in Combination With Avastin for People With the Most Common Form of Liver Cancer

Friday, May 29, 2020 - 7:42pm

Serious adverse reactions (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm.

Key Points: 
  • Serious adverse reactions (Grade 3-4) occurred in 38% of people in the Tecentriq and Avastin arm.
  • For those who qualify, Genentech offers patient assistance programs for people taking Tecentriq through Genentech Access Solutions.
  • People were randomized 2:1 to receive the combination of Tecentriq and Avastin or sorafenib.
  • According to the American Cancer Society, it is estimated that more than 42,000 Americans will be diagnosed with liver cancer in 2020.

ENHERTU (fam-trastuzumab deruxtecan-nxki) Demonstrated Meaningful Clinical Activity in Patients With HER2-mutant Non-small Cell Lung Cancer in Interim Analysis of Phase II DESTINY-Lung01 Trial

Friday, May 29, 2020 - 1:00pm

The overall safety and tolerability profile of ENHERTU in DESTINY-Lung01 was consistent with that seen in the Phase I lung cancer trial and previously reported ENHERTU trials.

Key Points: 
  • The overall safety and tolerability profile of ENHERTU in DESTINY-Lung01 was consistent with that seen in the Phase I lung cancer trial and previously reported ENHERTU trials.
  • ENHERTU has not been approved in the United States for non-small cell lung cancer.
  • Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.

ENHERTU (fam-trastuzumab deruxtecan-nxki) Significantly Improved Tumor Response Rate and Overall Survival in HER2-positive Metastatic Gastric Cancer in Phase II DESTINY-Gastric01 Trial

Friday, May 29, 2020 - 1:00pm

The safety and tolerability profile of ENHERTU in DESTINY-Gastric01 was consistent with that observed in Phase I gastric cancer trial and previously reported ENHERTU trials.

Key Points: 
  • The safety and tolerability profile of ENHERTU in DESTINY-Gastric01 was consistent with that observed in Phase I gastric cancer trial and previously reported ENHERTU trials.
  • ENHERTU has not been approved in the United States for HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
  • This indication is approved under accelerated approval based on tumor response rate and duration of response.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.

Deciphera Pharmaceuticals Announces Presentations of Positive Patient Reported Outcomes Results from INVICTUS Phase 3 Study of QINLOCKTM (ripretinib) in Patients with Fourth-Line Advanced GIST at the ASCO 2020 Virtual Scientific Program

Friday, May 29, 2020 - 1:00pm

These results were presented as part of the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.

Key Points: 
  • These results were presented as part of the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.
  • In addition to the impressive efficacy results shown in the INVICTUS Phase 3 study, QINLOCK was shown to have a favorable safety profile.
  • In the QINLOCK arm, grade 1-2 alopecia occurred in 44 patients (52%) and grade 1-2 PPES occurred in 18 patients (21%).
  • QINLOCK, the QINLOCK logo, Deciphera, Deciphera Pharmaceuticals, and the Deciphera logo are trademarks of Deciphera Pharmaceuticals, LLC.

RGENIX Shows Clinical Activity of Novel Agent RGX-202 in Patients with KRAS Mutant Colorectal Cancer in Phase 1 Trial

Friday, May 29, 2020 - 1:02pm

Due to increased metabolic demand, KRAS mutant tumors are highly susceptible to blockade of SLC6a8.

Key Points: 
  • Due to increased metabolic demand, KRAS mutant tumors are highly susceptible to blockade of SLC6a8.
  • The target of RGX-202, the SLC6a8/CKB pathway, is over-expressed in several prevalent cancer types, including KRAS mutant colorectal cancer.
  • In a Phase 1 dose escalation, RGX-202 demonstrated clinical activity as a single agent in the KRAS mutant CRC setting.
  • A Phase 1b study assessing the safety and clinical activity of RGX-202 in combination with FOLFIRI is ongoing.

Boehringer Ingelheim receives positive CHMP opinion for a third nintedanib indication in pulmonary fibrosis1

Friday, May 29, 2020 - 12:38pm

We are very pleased with the Committees opinion, which can bring a new therapy to people where there are no currently approved treatment options available.

Key Points: 
  • We are very pleased with the Committees opinion, which can bring a new therapy to people where there are no currently approved treatment options available.
  • The positive opinion is based on the results of INBUILD, a randomized, double-blind, placebo-controlled, parallel-group phase III trial, which evaluated the efficacy, safety, and tolerability of nintedanib in patients with chronic fibrosing ILDs with a progressive phenotype.2 The primary endpoint was the annual rate of decline in forced vital capacity (FVC) in mL assessed over a 52-week period.
  • Patients on placebo lost 188mL lung volume over a year, while patients on nintedanib lost 81mL.
  • This was measured as adjusted annual rate of decline over 52 weeks and meant that nintedanib slowed the lung function decline by 57% versus placebo.2 The treatment effect of nintedanib in slowing FVC decline compared with placebo seen in INBUILD was consistent for all patients, regardless of the fibrotic pattern on high-resolution computed tomography (HRCT) and it was also consistent with the results in nintedanib trials studying patients with IPF and SSc-ILD.2,9,10,11
    In the trial, nintedanib was associated with numerical reductions in the risk of acute exacerbation or death versus placebo.2 Treatment benefit may also be accompanied by reduced worsening of patient-reported outcomes such as dyspnea and cough.12 In addition, the safety profile observed in INBUILD was consistent to what has been seen in IPF and SSc-ILD patients treated with nintedanib previously.2
    View source version on businesswire.com: https://www.businesswire.com/news/home/20200529005287/en/

LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test

Friday, May 29, 2020 - 12:57pm

Offering an end-to-end model, LetsGetCheckeds new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution.

Key Points: 
  • Offering an end-to-end model, LetsGetCheckeds new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution.
  • The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis, offering convenient and secure results in 24 hours.
  • Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA.
  • The at-home Coronavirus test is accompanied by LetsGetCheckeds connected platform offering 24/7 telehealth services supported by licensed healthcare professionals and timely guidance on containment and care for those who test positive.

AVEO Oncology Announces TIVO-3 Final Overall Survival Results Featured at ASCO 2020 Virtual Scientific Program and Submitted to U.S. FDA as Part of NDA Filing

Friday, May 29, 2020 - 12:00pm

A copy of the poster will be available at the ASCO virtual meeting beginning today, May 29, 2020, at 8:00 AM ET.

Key Points: 
  • A copy of the poster will be available at the ASCO virtual meeting beginning today, May 29, 2020, at 8:00 AM ET.
  • Tivozanib has the potential to define highly refractory kidney cancer treatment, an area with no current evidence-based standard of care.
  • In connection with this announcement, AVEO will host a conference call and audio webcast today, May 29, 2020, at 8:30 am Eastern Time.
  • AVEOs earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb).

Gynesonics Receives FDA Clearance to Market Next Generation Sonata® System 2.1

Thursday, May 28, 2020 - 3:30pm

Gynesonics, a womens healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation (TFA).

Key Points: 
  • Gynesonics, a womens healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation (TFA).
  • FDA clearance for our advanced Sonata System 2.1 is a noteworthy achievement.
  • The Sonata System, including the SMART Guide, enables the operator to target fibroids and optimize ablations within them.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

AIROS Medical Launches New Compression Therapy Device and Garment System to Treat Breast Cancer Patients

Thursday, May 28, 2020 - 2:00pm

AIROS Medical, Inc., a medical technology manufacturer specializing in compression therapy products that treat cancer-related lymphedema and venous complications, today announced the launch of its updated AIROS 6 Sequential Compression Therapy device and Arm Plus garments following multiple regulatory approvals.

Key Points: 
  • AIROS Medical, Inc., a medical technology manufacturer specializing in compression therapy products that treat cancer-related lymphedema and venous complications, today announced the launch of its updated AIROS 6 Sequential Compression Therapy device and Arm Plus garments following multiple regulatory approvals.
  • We are excited to launch our advanced AIROS 6 device system as it will provide a new treatment option for breast cancer patients battling lymphedema, including those who utilize Medicare, says Gerald Makoid, CEO and president of AIROS Medical.
  • According to the National Cancer Institute, 45% of female breast cancer patients are over the age of 65.
  • AIROS Medical, Inc. is a medical technology manufacturer, designer, and specification developer specializing in compression therapy.