IBI351 Receives Breakthrough Therapy Designation in China for Previously Treated Advanced CRC
May 16th 2023China’s National Medical Products Administration has granted a breakthrough therapy designation to the KRAS G12C inhibitor IBI351 as monotherapy for previously treated patients with advanced colorectal carcinoma harboring a KRAS G12C mutation.
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FDA Issues Complete Response Letter for Trastuzumab Duocarmazine in Advanced HER2+ Breast Cancer
May 15th 2023The FDA has issued a complete response letter to the biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer.
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Neoadjuvant Atezolizumab Plus Chemotherapy Numerically Improves Survival in Early TNBC
May 12th 2023The addition of atezolizumab to neoadjuvant chemotherapy generated numerical improvements in event-free survival, disease-free survival, and overall survival compared with chemotherapy plus placebo in patients with early-stage triple-negative breast cancer.
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FDA Issues Complete Response Letter to BLA for N-803 in BCG-unresponsive NMIBC in Situ
May 11th 2023The FDA has issued a complete response letter regarding the biologics license application for N-803 in combination with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without Ta or T1 disease.
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Ivosidenib Wins European Approval for IDH1-mutated AML and Cholangiocarcinoma
May 10th 2023The European Commission has approved ivosidenib tablets in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia with an IDH1 R132 mutation who are not eligible to receive standard induction chemotherapy, and as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who received at least 1 prior line of systemic therapy.
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China Approves Zanubrutinib in Previously Untreated CLL/SLL and Waldenström Macroglobulinemia
May 8th 2023China’s National Medical Products Administration has approved 2 supplemental new drug applications of zanubrutinib for use in treatment-naïve adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma and Waldenström macroglobulinemia.
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Sintilimab Plus Chemo With or Without IBI305 Provides PFS Benefit in EGFR TKI–Pretreated EGFR+ NSCLC
May 8th 2023The combination of sintilimab and chemotherapy with or without the bevacizumab biosimilar IBI305 produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after treatment with an EGFR TKI.
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FDA Grants 501K Clearance to Bladder EpiCheck for Surveillance in NMIBC
May 5th 2023The FDA has granted 510K clearance to Bladder EpiCheck for use as a noninvasive method for surveillance of tumor recurrence in previously diagnosed patients with non–muscle invasive bladder cancer, in conjunction with cystoscopy.
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Liso-cel Earns European Approval for Relapsed/Refractory LBCL After 1 Prior Therapy
May 3rd 2023The European Commission has approved lisocabtagene maraleucel for the treatment of adult patients with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
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First-line Cemiplimab Plus Chemo Wins Approval in Canada for Advanced NSCLC
May 2nd 2023Health Canada has approved the combination of cemiplimab and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer without EGFR, ALK, or ROS1 aberrations who are not candidates for definitive chemoradiation.
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FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS
May 1st 2023The FDA has granted a priority review to the supplemental biologics license application seeking to expand the current indication of luspatercept to include treatment of anemia in patients with very low- to intermediate-risk myelodysplastic syndrome who have not previously received erythropoiesis-stimulating agents and who may require red blood cell transfusions.
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AUA Releases Clinical Practice Guideline for Nonmetastatic Upper Tract Urothelial Carcinoma
April 27th 2023The American Urological Association and Society of Urologic Oncology have released a clinical practice guideline for the diagnosis and management of patients with nonmetastatic upper tract urothelial carcinoma.
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ASTRO/ESTRO Release Clinical Guideline for Local Therapy in Oligometastatic NSCLC
April 26th 2023The American Society for Radiation Oncology and European Society for Radiotherapy & Oncology have released the first clinical guideline on the use of definitive local therapy, including radiation and surgery, for the treatment of patients with oligometastatic non–small cell lung cancer.
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Tislelizumab Plus Chemotherapy Meets OS End Point in Advanced Gastric/GEJ Adenocarcinoma
April 21st 2023The combination of tislelizumab plus chemotherapy elicited a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy plus placebo in patients with advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
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FDA Extends Review for Quizartinib in Newly Diagnosed FLT3-ITD+ AML
April 21st 2023The FDA has extended the review period for a new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia.
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VB10.16 Plus Atezolizumab Generates Positive Survival Data in PD-L1+ Advanced Cervical Cancer
April 20th 2023The combination of the potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate VB10.16 and atezolizumab elicited a median overall survival greater than 25 months in patients with PD-L1–positive, human papillomavirus 16–positive advanced cervical cancer.
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FDA Grants Fast Track Designation to Botensilimab Plus Balstilimab in Non–MSI-H/dMMR mCRC
April 20th 2023The FDA has granted a fast track designation to the combination of botensilimab plus balstilimab for the treatment of patients with non–microsatellite instability–high/mismatch repair–deficient metastatic colorectal cancer with no active liver involvement.
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Pemigatinib generated efficacy and tolerability in previously treated patients with advanced/metastatic or unresectable solid tumors harboring activating FGFR mutations or fusions/rearrangements, including cholangiocarcinoma, central nervous system tumors, gynecologic tumors, and pancreatic cancer.
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Hemostatic Radiotherapy Represents Tool for Management of GI Bleeding in Advanced Cancer
April 18th 2023Hemostatic radiation is a method of managing bleeding in patients with gastrointestinal cancers or GI metastases from other primary tumors; however, a multidisciplinary team is required to implement this method, according to Marnee M. Spierer, MD, MBA.
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FDA Accepts sBLA for Ide-cel in Triple-class Exposed Relapsed/Refractory Myeloma
April 17th 2023The FDA has accepted a supplemental biologics license application seeking the approval of idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
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Pembrolizumab Plus Cisplatin/Gemcitabine Extends OS in Advanced Biliary Tract Cancer
April 16th 2023Pembrolizumab plus cisplatin and gemcitabine produced a statistically significant and clinically meaningful improvement in overall survival vs placebo plus cisplatin and gemcitabine in previously untreated patients with advanced biliary tract cancer, according to data from the phase 3 KEYNOTE-966 trial.
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Intermittent Dosing Helps Mitigate Thrombocytopenia Associated With Milademetan in Sarcomas
April 14th 2023Thrombocytopenia is a common adverse effect associated with treatment with the MDM2 inhibitor milademetan in patients with sarcomas and other solid tumors, and the effects of thrombocytopenia can be mitigated with an intermittent dosing schedule and managed with dose interruptions or reductions.
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