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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

CHMP Recommends Approval of GSK's Dostarlimab in Endometrial Cancer

The CHMP opinion is based on data from a Phase I/II study of dostarlimab in mismatch repair-deficient or microsatellite instability-high endometrial cancer.

In Brief This Week: Kura Oncology, Innovent Biologics, Iaso Biotherapeutics, Invitae, Hologic

News items for the week of Feb. 22, 2021.

FDA Approves Regeneron, Sanofi's Libtayo With Agilent PD-L1 CDx in Frontline NSCLC

Advanced NSCLC patients must have a PD-L1 expression tumor proportion score of 50 percent, and no EGFR, ALK, or ROS1 alterations, to receive the drug.

Seagen's Tukysa Combination Garners UK Approval for Advanced HER2-Positive Breast Cancer

The UK's Medicines and Healthcare products Regulatory Agency approved the agent together with trastuzumab and chemo based on the Phase II HER2CLIMB trial.

In Brief This Week: AstraZeneca, Merck, Amgen, Kintara Therapeutics, Dana Farber Cancer Institute

News items for the week of Feb. 15, 2021. 

Feb 19, 2021

Immunocore to Submit BLA for Tebentafusp in Uveal Melanoma This Year

Feb 16, 2021

AstraZeneca, Daiichi Sankyo's Enhertu Gets Conditional UK Approval in Metastatic Breast Cancer

Feb 12, 2021

In Brief This Week: Roche, Novartis, Basilea Pharmaceutica, Revolution Medicines, Genetron Health

Feb 12, 2021

UK's NICE Does Not Recommend Verzenio for Advanced Breast Cancer in Draft Guidance

Feb 05, 2021

FDA Approves Bristol Myers Squibb's CAR T-cell Therapy Breyanzi for Large B-cell Lymphoma

Feb 05, 2021

In Brief This Week: Janssen, Hologic, Guardant Health, More

Feb 05, 2021

Astellas' Xospata Receives Conditional Approval in Refractory AML in China

Feb 04, 2021

UK's NICE Recommends Keytruda Plus Chemo for Upfront NSCLC, Regardless of PD-L1 Expression

Feb 04, 2021

FDA Approves Merck KGaA's Tepmetko for Non-Small Cell Lung Cancer With METex14 Alterations

Feb 01, 2021

EMA Committee Recommends Approval for Incyte's Pemazyre in Bile Duct Cancer

Jan 29, 2021

In Brief This Week: Janssen, Amgen, Daiichi Sankyo, AstraZeneca, Interpace Biosciences

Jan 28, 2021

Takeda Announces Updated Data From Mobocertinib Study in EGFR Exon20-Mutated NSCLC

Jan 26, 2021

Merck Nabs EU Keytruda Approval for MSI-High, Mismatch Repair Deficient Colorectal Cancer

Jan 20, 2021

Daiichi Sankyo, AstraZeneca's Enhertu Approved in EU for HER2-Positive Breast Cancer

Jan 19, 2021

FDA Approves Daiichi Sankyo, AstraZeneca's Enhertu for Gastric, Gastroesophageal Junction Cancer

Jan 15, 2021

FDA Approves Pfizer's Xalkori for Pediatric ALK-Positive Lymphoma

Jan 14, 2021

JP Morgan Healthcare, Day 3 and 4: ImmunoGen, Precigen, Autolus, Exact Sciences, Jounce, and More

Jan 13, 2021

JP Morgan Healthcare, Day 2: Eli Lilly, Pfizer, GlaxoSmithKline, Clovis Oncology, Invitae, and More

Jan 12, 2021

JP Morgan Healthcare, Day 1: Merck KGaA, Mirati, Agios, Tempus, Bristol Myers, Amgen, and More

Jan 11, 2021

Illumina CEO Discusses Pan-Cancer IVD Assay, CDx Collaborations at JP Morgan

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In Regulatory News & FDA Approvals

  1. CHMP Recommends Approval of GSK's Dostarlimab in Endometrial Cancer

  2. In Brief This Week: Kura Oncology, Innovent Biologics, Iaso Biotherapeutics, Invitae, Hologic

  3. FDA Approves Regeneron, Sanofi's Libtayo With Agilent PD-L1 CDx in Frontline NSCLC

  4. Seagen's Tukysa Combination Garners UK Approval for Advanced HER2-Positive Breast Cancer

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