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FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.
Royce M, Osgood CL, Amatya AK, Fiero MH, Chang CJG, Ricks TK, Shetty KA, Kraft J, Qiu J, Song P, Charlab R, Yu J, King KE, Rastogi A, Janelsins B, Weinberg WC, Clouse K, Borders-Hemphill V, Brown L, Gomez-Broughton C, Li Z, Nguyen TT, Qiu Z, Ly AT, Chang S, Gao T, Tu CM, King-Kallimanis B, Pierce WF, Chiang K, Lee C, Goldberg KB, Leighton JK, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. Royce M, et al. Among authors: song p. Clin Cancer Res. 2022 Apr 14;28(8):1487-1492. doi: 10.1158/1078-0432.CCR-21-3247. Clin Cancer Res. 2022. PMID: 34916216 Free PMC article. Clinical Trial.
Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary.
Thornton K, Kim G, Maher VE, Chattopadhyay S, Tang S, Moon YJ, Song P, Marathe A, Balakrishnan S, Zhu H, Garnett C, Liu Q, Booth B, Gehrke B, Dorsam R, Verbois L, Ghosh D, Wilson W, Duan J, Sarker H, Miksinski SP, Skarupa L, Ibrahim A, Justice R, Murgo A, Pazdur R. Thornton K, et al. Among authors: song p. Clin Cancer Res. 2012 Jul 15;18(14):3722-30. doi: 10.1158/1078-0432.CCR-12-0411. Epub 2012 Jun 4. Clin Cancer Res. 2012. PMID: 22665903 Clinical Trial.
First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer.
Blumenthal GM, Scher NS, Cortazar P, Chattopadhyay S, Tang S, Song P, Liu Q, Ringgold K, Pilaro AM, Tilley A, King KE, Graham L, Rellahan BL, Weinberg WC, Chi B, Thomas C, Hughes P, Ibrahim A, Justice R, Pazdur R. Blumenthal GM, et al. Among authors: song p. Clin Cancer Res. 2013 Sep 15;19(18):4911-6. doi: 10.1158/1078-0432.CCR-13-1212. Epub 2013 Jun 25. Clin Cancer Res. 2013. PMID: 23801166
Radium Ra 223 dichloride injection: U.S. Food and Drug Administration drug approval summary.
Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R. Kluetz PG, et al. Among authors: song p. Clin Cancer Res. 2014 Jan 1;20(1):9-14. doi: 10.1158/1078-0432.CCR-13-2665. Epub 2013 Nov 4. Clin Cancer Res. 2014. PMID: 24190979 Clinical Trial.
U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive.
Malik SM, Maher VE, Bijwaard KE, Becker RL, Zhang L, Tang SW, Song P, Liu Q, Marathe A, Gehrke B, Helms W, Hanner D, Justice R, Pazdur R. Malik SM, et al. Among authors: song p. Clin Cancer Res. 2014 Apr 15;20(8):2029-34. doi: 10.1158/1078-0432.CCR-13-3077. Epub 2014 Feb 26. Clin Cancer Res. 2014. PMID: 24573551
FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer.
Amiri-Kordestani L, Blumenthal GM, Xu QC, Zhang L, Tang SW, Ha L, Weinberg WC, Chi B, Candau-Chacon R, Hughes P, Russell AM, Miksinski SP, Chen XH, McGuinn WD, Palmby T, Schrieber SJ, Liu Q, Wang J, Song P, Mehrotra N, Skarupa L, Clouse K, Al-Hakim A, Sridhara R, Ibrahim A, Justice R, Pazdur R, Cortazar P. Amiri-Kordestani L, et al. Among authors: song p. Clin Cancer Res. 2014 Sep 1;20(17):4436-41. doi: 10.1158/1078-0432.CCR-14-0012. Epub 2014 May 30. Clin Cancer Res. 2014. PMID: 24879797 Clinical Trial.
FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.
Khozin S, Blumenthal GM, Zhang L, Tang S, Brower M, Fox E, Helms W, Leong R, Song P, Pan Y, Liu Q, Zhao P, Zhao H, Lu D, Tang Z, Al Hakim A, Boyd K, Keegan P, Justice R, Pazdur R. Khozin S, et al. Among authors: song p. Clin Cancer Res. 2015 Jun 1;21(11):2436-9. doi: 10.1158/1078-0432.CCR-14-3157. Epub 2015 Mar 9. Clin Cancer Res. 2015. PMID: 25754348 Clinical Trial.
FDA Approval: Blinatumomab.
Przepiorka D, Ko CW, Deisseroth A, Yancey CL, Candau-Chacon R, Chiu HJ, Gehrke BJ, Gomez-Broughton C, Kane RC, Kirshner S, Mehrotra N, Ricks TK, Schmiel D, Song P, Zhao P, Zhou Q, Farrell AT, Pazdur R. Przepiorka D, et al. Among authors: song p. Clin Cancer Res. 2015 Sep 15;21(18):4035-9. doi: 10.1158/1078-0432.CCR-15-0612. Clin Cancer Res. 2015. PMID: 26374073
U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.
Singh H, Brave M, Beaver JA, Cheng J, Tang S, Zahalka E, Palmby TR, Venugopal R, Song P, Liu Q, Liu C, Yu J, Chen XH, Wang X, Wang Y, Kluetz PG, Daniels SR, Papadopoulos EJ, Sridhara R, McKee AE, Ibrahim A, Kim G, Pazdur R. Singh H, et al. Among authors: song p. Clin Cancer Res. 2017 Jan 15;23(2):330-335. doi: 10.1158/1078-0432.CCR-16-1073. Epub 2016 Oct 28. Clin Cancer Res. 2017. PMID: 27793960 Clinical Trial.
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.
Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R. Balasubramaniam S, et al. Among authors: song p. Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27. Clin Cancer Res. 2017. PMID: 28751443
4,265 results