Trial 2. International regulatory history for Opdivo at time of submission to TGA. Country Indication Approval Date Indication number/ Actual / Best Submission Date Planned Actual / Planned US 1) 30 Jul 2014 1) 22 Dec 2014 1) 2/3 Line melanoma ORR 2) 22 Dec 2014 2) 04 Mar 2015 2) Previously treated 3) 27 Feb 2015 3) Nov 2015 Squamous NSCLC 4) 30 Mar 2015 4) 30 Sep 2015 3) 1L mono melanoma 5) 02 July 2015 5) 09 Oct 2015 066 6) 22 July 2015 6) Jan 2016 4) 1L melanoma combination with 7) 15 Sep 2015 7) Mar 2016 Yervoy (069) 5) Non SQ NSCLC (057) 6) combo melanoma w/IPI 067 7) Renal Cell (025) OS EU 1, 2) 04 Sept 2014 1) 19 Jun 2015 1) Advanced metastatic melanoma (2 parallel 2) 20 July 2015 submissions) 2) Previously treated 3) 1Q2016 Sq NSCLC (name 3) 08 July 2015 4) 1Q2016 reconciliation 4) 08 July 2015 approved 24 Sep 5) 3Q2016 2015) 5) 13 Oct 2015 3) 1L melanoma combination with Yervoy 4) Non Sq 5) Renal Australia 1, 2, 3) 07 Jan 1, 2, 3) Feb 2016 1) monotherapy 2015 advanced melanoma 4) Best: Feb 4) 31 Aug 2015 2016 Base: Sep 2) combination with 2016 Yervoy 1L melanoma 5) 07 Dec 2015 5) 4Q 2016 3) Previously treated SQ NSCLC; 4) NSQ NSCLC: TGA allowed addition as parallel submission 5) Renal 2/3L
2. International regulatory history for Opdivo at time of submission to TGA. Country Indication number/ Submission Date Actual / Planned Approval Date Actual / Best Planned Indication US 1) 30 Jul 2014 2) 22 Dec 2014 3) 27 Feb 2015 4) 30 Mar 2015 5) 02 July 2015 6) 22 July 2015 7) 15 Sep 2015 1) 22 Dec 2014 2) 04 Mar 2015 3) Nov 2015 4) 30 Sep 2015 5) 09 Oct 2015 6) Jan 2016 7) Mar 2016 1) 2/3 Line melanoma ORR 2) Previously treated Squamous NSCLC 3) 1L mono melanoma 066 4) 1L melanoma combination with Yervoy (069) 5) Non SQ NSCLC (057) 6) combo melanoma w/IPI 067 7) Renal Cell (025) OS EU 1, 2) 04 Sept 2014 (2 parallel submissions) 3) 08 July 2015 4) 08 July 2015 5) 13 Oct 2015 1) 19 Jun 2015 2) 20 July 2015 3) 1Q2016 4) 1Q2016 5) 3Q2016 1) Advanced metastatic melanoma 2) Previously treated Sq NSCLC (name reconciliation approved 24 Sep 2015) 3) 1L melanoma combination with Yervoy 4) Non Sq 5) Renal Australia 1, 2, 3) 07 Jan 2015 4) 31 Aug 2015 5) 07 Dec 2015 1, 2, 3) Feb 2016 4) Best: Feb 2016 Base: Sep 2016 5) 4Q 2016 1) monotherapy advanced melanoma 2) combination with Yervoy 1L melanoma 3) Previously treated SQ NSCLC; 4) NSQ NSCLC: TGA allowed addition as parallel submission 5) Renal 2/3L Trial