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Brukinsa Now FDA Approved for Patients with CLL or SLL
FDA Approvals, News & Updates
,
Leukemia
,
Lymphoma
February 2023, Vol 14, No 1
On
January 19, 2023
, the FDA approved zanubrutinib (Brukinsa; BeiGene USA), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA granted zanubrutinib an orphan drug designation for this indication.
Read More
Tukysa, in Combination with Trastuzumab, Now FDA Approved for HER2-Positive, Unresectable or Metastatic Colorectal Cancer
FDA Approvals, News & Updates
,
Colorectal Cancer
February 2023, Vol 14, No 1
On
January 19, 2023
, the FDA accelerated the approval of tucatinib (Tukysa; Seagen), a Bruton tyrosine kinase inhibitor, in combination with trastuzumab (Herceptin), a HER2/
neu
receptor agonist, for the treatment of
RAS
wild-type,
HER2
-positive, unresectable or metastatic colorectal cancer (CRC) that progressed after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies.
Read More
Keytruda Received FDA Approval for Adjuvant Treatment of NSCLC
FDA Approvals, News & Updates
,
Lung Cancer
February 2023, Vol 14, No 1
On
January 26, 2023
, the FDA approved pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, as monotherapy for adjuvant treatment of patients with stage IB (T2a ≥4 cm), II, or IIIA non–small-cell lung cancer (NSCLC), after resection and platinum-based chemotherapy.
Read More
Krazati Receives Accelerated FDA Approval for NSCLC with KRASᴳ¹²ᶜ Mutation
FDA Approvals, News & Updates
,
Lung Cancer
February 2023, Vol 14, No 1
On
December 12, 2022
, the FDA accelerated the approval of adagrasib (Krazati; Mirati Therapeutics), a RAS GTPase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and
KRAS
G12C
mutation (as determined by an FDA-approved test) who have received at least 1 systemic therapy.
Read More
Adstiladrin, First Adenoviral Vector–Based Gene Therapy, FDA Approved for High-Risk Non–Muscle Invasive Bladder Cancer
FDA Approvals, News & Updates
,
Bladder Cancer
,
Genitourinary Cancers
February 2023, Vol 14, No 1
On
December 22, 2022
, the FDA accelerated the approval of mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication breakthrough therapy and orphan drug designations.
Read More
Orserdu FDA Approved for ER-Positive, Advanced or Metastatic Breast Cancer with ESR1 Mutation
FDA Approvals, News & Updates
,
Breast Cancer
February 2023, Vol 14, No 1
On
January 27, 2023
, the FDA approved elacestrant (Orserdu; Stemline Therapeutics), an estrogen receptor (ER) antagonist, for the treatment of postmenopausal women or adult men with ER-positive,
HER2
-negative advanced or metastatic breast cancer and an
ESR1
mutation whose disease progressed after ≥1 line of endocrine therapy.
Read More
Ribociclib plus Endocrine Regimen Outperforms Combination Chemotherapy in Advanced Breast Cancer
By
Phoebe Starr
SABCS Highlights
,
Breast Cancer
February 2023, Vol 14, No 1
Patients with hormone receptor (HR)-positive,
HER2
-negative advanced breast cancer, including those with visceral crises, treated with the CDK4/6 inhibitor ribociclib (Kisqali) plus endocrine therapy had a significantly longer progression-free survival (PFS) and fewer adverse events (AEs) compared with those treated with combination chemotherapy, according to results from the phase 2 RIGHT Choice trial.
Read More
Survey Results Provide Insights into Biosimilar Use at Cancer Centers
By
Wayne Kuznar
Biosimilars
,
ASCO 2022 Highlights
February 2023, Vol 14, No 1
Results from a survey of cancer centers revealed that 66% of responding institutions had a biosimilar interchangeability policy in place, but barriers to adoption remain an issue.
Read More
Zanubrutinib Superior to Ibrutinib in Patients with Relapsed or Refractory CLL/SLL
By
Phoebe Starr
ASH Highlights
,
Leukemia
,
Lymphoma
February 2023, Vol 14, No 1
A head-to-head phase 3 clinical trial in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) has found that zanubrutinib (Brukinsa), a next-generation Bruton tyrosine kinase (BTK) inhibitor, is more effective at preventing disease progression and better tolerated than ibrutinib (Imbruvica), a first-generation BTK inhibitor that has been the current standard of care for this population of patients.
Read More
GC012F, an Autologous BCMA and CD19 Dual-Targeting CAR T-Cell Therapy, as First-Line Treatment for Transplant-Eligible Patients with Newly Diagnosed High-Risk Multiple Myeloma
Multiple Myeloma
2022 Year in Review - Multiple Myeloma
A phase 1 trial of GC012F demonstrated an overall response rate of 100% in high-risk, transplant-eligible patients with newly diagnosed multiple myeloma.
Read More
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Home
Issues
Online First
Latest Issue
Issue Archive
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Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
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Conference Correspondent
SABCS 2023 - HER2+ MBC
ASCO 2023 - Breast Cancer
Web Exclusives
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Prostate Cancer Diagnostics Monthly Minutes
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